Apparatus and methods for fracture repair

ABSTRACT

Apparatus and methods for bone fracture repair. The apparatus may include a structural support for positioning a first bone segment relative to a second bone segment. The apparatus may include an anchoring substrate. The anchoring substrate may be configured to compress the first bone segment to the second bone segment. The anchoring substrate may transmit tension from a distal bone segment anchor in the first bone segment to a proximal bone segment anchor in the second bone segment. The apparatus may be configured to be deployed percutaneously in an inner cavity of a bone. The apparatus may be installed in an open fracture. The apparatus may be expanded, self-expanding or configured for mechanically actuation. Some embodiments of the apparatus may include a central axis member that may be used in conjunction with expansion of one or both of the structural support and the anchoring substrate to configure the apparatus.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a nonprovisional of U.S. Provisional ApplicationsNos. 61/020,778, filed on Jan. 14, 2008, and 61/090,999, filed on Aug.22, 2008, both of which are hereby incorporated by reference in theirentireties.

FIELD OF TECHNOLOGY

Aspects of the disclosure relate to providing apparatus and methods forrepairing bone fractures. In particular, the disclosure relates toapparatus and methods for repairing bone fractures utilizing a devicethat is inserted into a bone.

BACKGROUND

Currently, there are many known ways to treat long bone fractures.Common fracture treatments include: (1) non-surgical immobilization; (2)osteosuture and tension band technologies; (3) percutaneous fixation(e.g., using pins, wires, screws etc.); (4) rigid intramedullary nailing(e.g., using a large rod and external screws); (5) flexible plateosteosynthesis (e.g., a “load sharing” suture); (6) arthroplasty (e.g.,using a prosthesis); (7) plating and other indication-specifictechniques. Severe fractures that meet certain clinical criteria mayrequire surgical repair rather than non-surgical immobilization.

The midshaft of an elongated or long bone is typically classified as thediaphysis. The end of such a bone is typically classified as theepiphysis. Bone that is transitional between the midshaft and the end istypically classified as the metaphysis.

Metaphysis and epiphysis bone are typically less dense, more cancellous(porous), and less cortical than diaphysis bone. Repair of metaphysisand epiphysis fractures are often complicated by their proximity to ajoint. Because of such bone quality and anatomical differences, fixationof plates and screws in metaphysis and epiphysis bone is typically moredifficult than fixation of plates and screws in diaphysis bone. This maybe especially true if the patient is elderly and suffers fromosteoporosis.

In general, fracture fixation may provide longitudinal (along the longaxis of the bone), transverse (across the long axis of the bone), androtational (about the long axis of the bone) stability. Fracturefixation may also preserve normal biologic and healing function.

There are two primary categories for surgical fixation: (1) a devicethat is within the skin (internal fixation); and (2) a device thatextends out of the skin (external fixation). There are two common typesof internal fixation approaches for long bone surgery (a) a plate thatis screwed to the outside of the bone; or (b) a rod that goes down thecenter of the bone.

Plates and screws are characterized by relatively invasive surgery,support of fractured bone segments from one side outside of bone, andscrews that anchor into the plate and through the entire bone.Successful repair is dependent on fracture pattern, bone quality,physician skill set, and patient tolerance of a foreign body. Plates andscrews may not properly address the alignment and stability requirementsfor periarticular and intrarticular fractures.

Intramedullary rods or nails, such as those used in mid shafttreatments, are more effective than plates and screws at minimizingsoft-tissue trauma and complications. However, rods and nails often donot stabilize multi-segment fractures in many cases. The typicalintramedullary rod or nail is fixed in diameter and is introduced intothe medullary canal through an incision. In cases where there is amedullary plenum larger than the rod, rotational and transversestability may be compromised. If a larger rod is used, reaming of theentire shaft length may be necessary. Such reaming may thin out existingcortical bone support. Also, predetermined threaded screw holes in therods may limit the ways in which different fracture patterns can bereduced and stabilized.

Flexible intramedullary rod-like solutions utilize structures that canbe inserted into the medullary cavity through an access site, which canthen become rigid. These solutions may be easier for the user to installthan rigid intramedullary rods. These structures may be reinforced withpolymers or cements. Flexible intramedullary solutions, similar to rigidintramedullary rods, may have limited benefits for periarticular orintrarticular fractures. Multi-segment fractures, of either the midshaftor end-bone, require alignment and stability in a manner that generatesadequate fixation in multiple directions.

Midshaft fractures and end-bone fractures are fundamentally different.The loading conditions, fracture patterns, alignment needed, andcompression force to promote healing are different. Midshaft fractureshave ample bone material on either side of the fracture in which anchorsmay be driven. End-bone fractures, especially on the articular surfacemay have thin cortical bone, soft cancellous bone, and minimal anchoringlocations.

Midshaft fractures tend to be loaded primarily in bending and torsion.End-bone fractures tend to be loaded in complex and multi-directionalstress patterns. Midshaft repair approaches, therefore, may not beappropriate for repair of end-bone fractures.

Appropriate sizing of an implant helps realignment and healing of thefracture. As a result, many different sizes of known repair products areoften stored in inventories to ensure proper matching of the implantdevice to a patient's anatomy. The inventories may be a burden tohospitals and insurance carriers, but they may be necessary to provideto a surgeon intraoperative flexibility.

It would be desirable, therefore, to provide apparatus and methods forproper anatomic alignment and stabilization, while reducing trauma andcomplications.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects and advantages of the invention will be apparent uponconsideration of the following detailed description, taken inconjunction with the accompanying drawings, in which like referencecharacters refer to like parts throughout, and in which:

FIG. 1 is a side view of apparatus in accordance with the principles ofthe invention disposed;

FIG. 1A is a perspective view of the apparatus shown in FIG. 1;

FIG. 1B is a partial sectional view of the apparatus shown in FIG. 1A;

FIG. 1C is front view of the apparatus shown in FIG. 1A in accordancewith the principles of the invention;

FIG. 2 is a front view of an illustrative human skeleton;

FIG. 3 is a partial sectional view of a fractured bone;

FIG. 4 is a perspective view showing a body portion that may be treatedusing the apparatus shown in FIG. 1;

FIG. 5 is a perspective view showing the a portion of the body portionshown in FIG. 4;

FIG. 6 is a sectional view of apparatus in accordance with theprinciples of the invention;

FIG. 7 is a sectional view of apparatus shown in FIG. 6 along withadditional apparatus in accordance with the principles of the invention;

FIG. 8 is a sectional view of apparatus shown in FIG. 1 along withadditional apparatus in accordance with the principles of the invention;

FIG. 9 is a partial sectional view of apparatus shown in FIG. 1 alongwith additional apparatus in accordance with principles of theinvention;

FIG. 10 is a partial sectional view showing the use of the apparatusshown in FIG. 1 along with additional apparatus in accordance with theprinciples and methods of the invention;

FIG. 11 is a partial sectional view of the apparatus shown in FIG. 1along with additional apparatus in accordance with the principles of theinvention;

FIG. 12 is a partial sectional view of the apparatus shown in FIG. 1along with additional apparatus in accordance with the principles of theinvention;

FIG. 13 is a partial sectional view of the apparatus shown in FIG. 1along with additional apparatus in accordance with the principles of theinvention;

FIG. 14 is a partial sectional view of the apparatus shown in FIG. 1along with additional apparatus in accordance with the principles of theinvention;

FIG. 15 is a partial sectional view of the apparatus shown in FIG. 1along with additional apparatus in accordance with the principles of theinvention;

FIG. 16 is a partial sectional view of the apparatus shown in FIG. 1along with additional apparatus in accordance with the principles of theinvention;

FIG. 17 is a partial sectional view of the apparatus shown in FIG. 1along with additional apparatus in accordance with the principles of theinvention;

FIG. 18 is a partial sectional view of apparatus in accordance with theprinciples of the invention;

FIG. 19 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 20 is a partial sectional view of apparatus in accordance with theprinciples of the invention;

FIG. 21 is an end view of the apparatus shown in FIG. 20;

FIG. 22 is a partial sectional view of apparatus shown in FIG. 1;

FIG. 23 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 24 is a partial sectional view of the apparatus shown in FIG. 23;

FIG. 25 is a side view of apparatus in accordance with the principles ofthe invention;

FIG. 26 is a side view of apparatus in accordance with the principles ofthe invention;

FIG. 27 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 28A is a side view of apparatus in accordance with the principlesof the invention;

FIG. 28B is a side view of apparatus in accordance with the principlesof the invention;

FIG. 28C is a partial sectional view of apparatus in accordance with theprinciples of the invention;

FIG. 29 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 30 is sectional view of a portion of the apparatus shown in FIG.29;

FIG. 31 is a side view of apparatus in accordance with the principles ofthe invention;

FIG. 32 is a sectional view of apparatus shown in FIG. 31;

FIG. 33 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 34 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 35 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 36 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 37 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 38 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 39 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 40 is a partial sectional view of apparatus shown in FIG. 39;

FIG. 41 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 42 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 43 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 44 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 45 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 46 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 47 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 48 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 49 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 50 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 51 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 52 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 53 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 54 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 55 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 56A is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 56B is a side view of the apparatus shown in FIG. 56A;

FIG. 56C is an end view of the apparatus shown in FIG. 56A;

FIG. 57A is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 57B is a side view of the apparatus shown in FIG. 57A;

FIG. 57C is an end view of the apparatus shown in FIG. 57A;

FIG. 58 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 59 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 60 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 61 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 62 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 63 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 64 is a side view of apparatus in accordance with the principles ofthe invention inside a body portion;

FIG. 65 is a perspective view showing the use of apparatus in accordancewith the principles of the invention;

FIG. 66 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 67 is a perspective view of apparatus in accordance with theprinciples of the invention; and

FIG. 68 is an illustrative flow diagram that shows a method inaccordance with the principles of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Apparatus and methods for fracture repair are provided. The apparatusmay include a structural support for positioning a first bone segmentrelative to a second bone segment. The structural support may beconfigured to be deployed in an inner cavity of a bone. The apparatusmay include an anchoring substrate. The anchoring substrate may beconfigured to compress the first bone segment to the second bonesegment. The anchoring substrate may be configured to be deployed in theinner cavity.

The term “bone segment” may refer to portions or fragments of a bone.The term “structural support” may include a “structural cage.”

The structural support may be self-expanding. The structural support maybe expanded by balloon. The structural support may be expanded bymechanical actuation. The anchoring substrate may be self-expanding. Theanchoring substrate may be expanded by balloon. The anchoring supportmay be expanded by mechanical actuation.

The structural support may be used as a frame to position and align thebone segments. Anchors may used to secure the bone segments to theanchoring substrate. The anchoring substrate may be tensioned tocompress the bone segments against each other. Some embodiments of theapparatus may include a central axis member. The central axis member maybe used in conjunction with expansion of one or both of the structuralsupport and the anchoring substrate. The central axis member may be usedin conjunction with the tensioning of the anchoring substrate afteranchors are placed. A proximal anchor may be used to fix one end of theapparatus to a bone segment to “lock in” the tensioning of the anchoringsubstrate.

The apparatus may include delivery apparatus. The delivery apparatus maydeliver one or more portions of the apparatus, such as the structuralsupport and the anchoring substrate, through an access hole in the boneand into the intramedullary cavity in the bone. The portions may bedelivered in a contracted or collapsed state. The portions may then beexpanded for repair of the fracture.

The apparatus and methods may involve reducing, aligning, compressingand/or stabilizing the fracture from within the intramedullary cavity.In some instances, the resulting stabilized bone may then heal whilemaintaining mobility of the patient.

The apparatus and methods may provide stabilization in axial bending,torsion, rotation, compression, and may provide inter-segment tension orcompression.

The stabilization may repair compacted and impacted fractures, controllength, and control alignment of the fracture segments. The apparatusmay separate the tasks of revision, reduction, fixation, stabilization,rotation and offset.

The apparatus and methods may distribute load between the apparatus andnative bone. The apparatus may have flexibility and modulus that aresimilar to native bone. Some embodiments may provide apparatus that isselectively weaker than or stronger than the native bone to promotebeneficial fracture healing response.

The apparatus and methods may be used for closed reduction, openreduction, and minimally invasive surgical procedures (“MIS”). Theapparatus and methods may facilitate arthroscopic surgical procedures.The apparatus and methods may provide percutaneous fracture repair. Insuch repair, the apparatus may be deployed into the cavity of a bonethrough a small incision.

The apparatus may be delivered at a point other than that of thefracture site. This may help reduce soft tissue damage. The apparatusmay be delivered into an intramedullary cavity through a small accesshole that may be placed along the midshaft of the long bone in an areain which minimal soft tissues would need to be displaced.

The apparatus and methods may reduce the need to place foreign bodies inmuscle, tendon and nerve areas. As such, the apparatus and methods mayreduce tissue erosion and disintegration. Preservation of the softtissue may reduce chronic pain and stiffness. The apparatus and methodsmay reduce infection risk because of its noninvasiveness.

In some embodiments, the apparatus and methods may be made completelyfrom biologically friendly metals such as titanium and Nitinol. Suchmaterials reduce the risk of infection and do not generally interferewith normal biological processes within the fractured bone.

The apparatus and methods may be used to repair many different types ofbones. For example, the apparatus and methods may be used to repair longbones, short bones, flat bones, irregular bones, and sesamoid bones.

The apparatus and methods may be used to repair many different types offractures. For example, the apparatus and methods may be used to repaircomminuted fractures, epiphyseal fractures, metaphyseal fractures, midshaft fractures, intra-articular fractures, periarticular fractures,multipart fractures and other types of fractures.

The apparatus may be used in the reconstruction of fractured joints. Theapparatus and methods may also facilitate such joint replacements byproviding an adequate anchoring substrate. For example, the apparatusand methods may provide stable anchoring for a prosthesis, and reduceaseptic loosening.

The terms “end-bone” and “end-bone fracture” may be used to refer tofractures that occur in the epiphyseal or metaphyseal region of longbones. Such fractures include peri-articular and intra-articularfractures.

The apparatus and methods may be used to treat osteoporotic bone,indications involving poor bone quality. In connection with suchindications, the apparatus may compensate for deficiencies in nativebone and may reduce concerns regarding stress shielding. The apparatusand methods may be used in connection with fusion of bones and jointsfor various indications including arthritis.

The apparatus and methods may be used in conjunction with bone cement orin place of bone cement. In some embodiments, the apparatus may act as abone filler. For example, the apparatus may be used for filling bonevoid in connection with the treatment of cysts and tumors. The apparatusmay behave as an osteoconductive scaffold to promote bone growth.

The apparatus and methods may be used in connection with provisionalalignment for staged repair procedures, such as revisions, high energytrauma, or other cases in which there is infection or soft tissue thatneeds to heal before bone fixation is completed. The apparatus andmethods may be used in combination with various antibiotics that promotehealing.

The structural support may prevent bone segments from moving inward, sothe apparatus may reduce the likelihood of collapse of the fracture. Theapparatus may conform to the shape of bone and may thus minimize unduestresses. For example, the apparatus and methods may reduce hoop stressby selecting a degree of implant expansion or stiffness.

The apparatus may be self-centering, because it expands into the bonecavity. Many of the cavities are not straight like a pipe; they varydepending on the anatomy. The apparatus may be straight, bent, curved,and cavity-compliant.

The apparatus and methods may provide anchoring at the distal end of theapparatus. This feature may be used for repairs of articular fracturesand fractures with small or mobile bone segments.

The apparatus and methods may provide for the use of small anchors,because the apparatus provides structural support for the bone segmentsthat require anchoring.

The apparatus and methods may provide anchoring in any suitabledirection. Some embodiments may provide anchoring in any plane.

Because the anchoring substrate expands toward the inside surface of thebone segments, relatively shorter anchors may be used in comparison withtypical repair methods. For the same reason, the use of a screw that islonger than required to engage the anchoring substrate will not resultin driving the screw into or through bone that is opposite the anchoredsegment. This is so because the screw will terminate in theintramedullary cavity.

The apparatus and methods may be used in conjunction with plates,screws, pins, external fixators, replacement joints, bone graftmatrices, factor based bone substitutes, and cell based bonesubstitutes.

Delivery Instrument

The delivery instrument may deliver the apparatus to the intramedullarycavity through an access hole in the bone. The delivery instrument maybe used to remove the apparatus from the intramedullary cavity throughthe access hole. The delivery instrument may engage the apparatus by anysuitable mechanism, including one or more of threading, a socket, a pin,a snap, a collet, a cable, and any other suitable mechanism.

The mechanism may deliver, expand, adjust, rotate, lock, release andrecapture the apparatus. Each of the acts, and other suitable acts, maybe performed independently on the structural cage, the anchor substrate,the central axis member, locking features, and associated couplingmechanisms. The delivery device may include a handle set capable ofdelivering the forces needed to actuate the mechanism or mechanisms.

The delivery instrument may include a sheath to help deliver theapparatus in a compacted state. The shaft of sheath may be bendable toaccess the intramedullary cavity. In some embodiments, the deliveryinstrument may not have a sheath. In those embodiments, the deliveryinstrument may push the apparatus into place unguarded.

The delivery instrument may be radio opaque in whole or in part.

In some embodiments, the delivery instrument may be attached to aflexible scope or endoscope. In some embodiments, the deliveryinstrument may be integrated with the flexible scope or endoscope.

Structural Support

The structural support may provide one or more of axial, bending,torsional, and positional structural support to the fracture segments.The structural support may reduce or eliminate adverse effects such asstress risers. The structural support may provide a guide or surface foralignment of the fracture segments during reduction and healing.

The structural support may be configured in a contracted state andintroduced through a hole in the shaft of the bone. The structuralsupport may have sufficient flexibility in the contracted state toconform to curvature in an access pathway.

The structural support may be positioned inside the intramedullarycavity near a fracture site. The structural support may be expanded.When expanded, the structural support may be rigid. The structuralsupport may be expanded sufficiently to fill the available cavity and/ordisplace low density material that may border the cavity. Expansion mayvary along the surface of the structural support such that the expandedstructural support may conform to irregular cavity shapes.

In some embodiments, an expansion state may be maintained with orwithout the structural support being in a stressed condition. Radialpressure against the cavity walls can be tailored along the length ofthe structural support. The structural support may provide strain reliefin desired locations to promote healing.

The expansion of the structural support may be elastic. This may beachieved using a spring material that returns to its originalconfiguration shape or pressure after release from the contracted state.

The expansion of the structural support may be plastic. The structuralsupport may be deformed into a desired expanded configuration. Thedeformation may be achieved by a mechanism, such as a lever orreciprocating manipulators that change the length of the structuralsupport. The lever or manipulators may shorten the distance between twoportions of the structural member. Shortening the distance may causeradial expansion of a portion of the structural support.

Force for shortening the distance may be supplied by a central axismember that may transect the structural support. The resulting shapecould be derived from a combination of the expansion described and theresistance of the cavity walls.

The deformation may be achieved by direct force, such as by a balloon.

The structural support may be expanded torsionally. The torsionalexpansion may be either elastic or plastic in nature. For example, thedistal end of the structural support may be rotated relative to theproximal end. The structural support may then expand to fill the cavity.

Many different materials could be utilized to achieve the desireexpansion and strength features described.

The structural support may include support members that form a cage or aportion of a cage. The support members may have one or more of manydifferent configurations. The structural support may have any suitablenumber of support members. For example, the number of support membersmay be 1, 2, 3, 4, 5, 6, 7, 8, 10, 25, 50, 100 or more.

The support members may have any suitable cross-sectional shape. Forexample, the support members may have one or more of the followingcross-sectional shapes: round, flat, rectangular, “I” beam, tubular,stranded, twisted and many others.

The structural support may have any suitable shape. For example, thestructural support may be round, cylindrical, flat, rectangular, spiral,helical, wisk or egg beater like, egg like or oval, branching orfree-ended.

The structural support may be constructed from unitary ormulti-component assemblies. The structural support may be: machined,laser cut form a tube, etched from a sheet, assembled and joined strips,molded, deposited and or sintered.

The proximal end of the structural support may join and lock to theanchor substrate. The proximal end may also interface with the deliveryinstrument. The proximal end may have suitable features for delivery,actuation, locking and release. Such features may include, for example,one or more thread, socket, pin, snap, collet, cable mechanisms andother suitable mechanism.

Anchoring Substrate

The apparatus may include one or more anchoring substrates. An anchoringsubstrate may receive one or more anchors and hold them in a desiredposition with or without the joint assistance of the structural supportand with or without cancellous bone. The anchoring substrate may besized and shaped such that it may be engaged by an anchor thatpenetrates into the intramedullary space.

The anchoring substrate may be sized and shaped such that once theanchoring element penetrates into the intramedullary space, theanchoring substrate may engage the anchor. The anchoring substrate mayprovide to an anchor tension that is supplemental to tension caused bythe engagement of the anchor and the anchoring substrate.

There are several methods by which the anchors and the anchoringsubstrate may engage.

Some of the methods are passive engagement methods. In passiveengagement, anchoring substrate features may be appropriately sized toengage an anchor. For example, the anchor and anchoring substrate may beconfigured such that they engage in a manner analogous to a screw andhole. A laser cut structure could take any shape necessary to achieveappropriate anchor engagement and retention. The receiving cavities(“cells”) could be round, square, slotted, triangle, or any shape thatfacilitated engagement. The geometry of the cells may be that of ashortening design. The cells may form a matrix, a “fabric,” or a“cloth.” The anchoring substrate may include a single layer or multiplelayers.

Matrix characteristics may be varied along an axis of the anchoringsubstrate to provide anchoring characteristics along the axis. Forexample, cell geometry may be varied to provide engagement withdifferent types of anchors. Anchoring substrate thickness may be variedto provide different degrees of anchor retention strength and forces.

There are several approaches to active engagement. One such approach iscell size reduction. The anchoring substrate may be deformed such thatthe size of cells is reduced. The cell size reduction may causetightening (or locking) of the cell onto the anchor.

Another such approach involves relative displacement between first andsecond anchoring substrates. The relative displacement effectivelyreduces cell size when corresponding cells are offset from each other.The relative displacement may be axial, rotational, radial, etc . . . .The relative displacement may trap an anchor between the two displacedanchoring substrates and effectively lock or hold the anchor. Cells ofselected shapes, either similar or different, in the first and secondanchoring substrates may be moved in a cooperative manner to trap orengage the anchor.

Another such approach involves twisting the anchoring substrate. Thisaction may be similar to stretching and locking the anchor in the mediumof the substrate. Other approaches include wrapping, plicating andbunching the anchoring substrate. A plicated or bunched configurationmay exert force by having several layers of material binding on theanchor at one time, effectively wire tying the anchor.

The arrangement of different portions of the anchoring substrate may beselected to facilitate engagement with an anchor. Portions of theanchoring substrate may extend radially away from a central orlongitudinal axis of the apparatus or the anchoring substrate. Portionsof the anchoring substrate may be supported in a perpendicularorientation with respect to the axis.

After the anchoring substrate is engaged with an anchor, the anchoringsubstrate may apply tension to the anchor. The tension may urge theanchor to move relative to the structural element. This can beaccomplished by moving the anchoring substrate in an axial directionrelative to the structural member. If the anchoring substrate is movedproximally relative to the structural support, tension would be appliedto the anchors and their corresponding fracture segments.

The tension may be achieved by reducing the diameter of the anchoringsubstrate. This can be accomplished though lengthening and thereforereducing the anchoring substrate diameter. The tension may be applied bywrapping, folding, twisting, rotating or radially pulling in theanchoring substrate. The plicated or bunched configuration mentionedabove may be used for this approach.

In some embodiments, the anchoring substrate may be internal to thestructural support. In some embodiments, the anchoring substrate may beexternal to the structural support. Some embodiments may include one ormore anchoring substrates that are internal to the structural supportand one or more anchoring substrates that are external to the structuralsupport. In some embodiments, the anchoring substrate may be attached tothe structural support.

In some embodiments, the anchoring substrate may cooperate mechanicallywith the structural support. The anchor substrate may provide structuralintegrity to the device. For example, the matrix may includeinterlockable features. The interlocking features may become interlockedduring or after the anchoring substrate is expanded.

In some embodiments, the anchoring substrate may be mechanicallyindependent of the structural support. This may allow for relativemovement between the anchoring substrate and the structural support.

The anchoring substrate may be expandable. The anchoring substrate mayexpand simultaneously with the structural support. The anchoringsubstrate may be expanded by the structural support. The anchoringsubstrate may be expanded by a delivery device such as a balloon. Thesubstrate may be self-expanding. Self-expanding embodiments may includespring like elements. Self-expanding embodiments may include elementsthat include shape memory materials, such as shape memory alloys. Insome embodiments, the anchoring substrate may be non-expanding. In someembodiments, the anchoring substrate may be expandable by mechanicalactuation.

The anchoring substrate may be constructed in many different forms andof many different materials. The forms may include, for example, braid,mesh, weave, strand, laser cut members, deposited members or otherfilament construction. The anchoring substrate cells may be roundelements, square element, rectangular elements, or profiled, or acombination of cell types. The anchor substrate cells may be designed tomimic bone and act as a growth or graft scaffold.

The anchoring substrate may be made form a unitary element such as anextruded tube or flat sheet with a pattern cut into it that wouldfacilitate engagement. Examples include a laser-cut tube, a stamped oretched sheet, and other suitable approaches.

The anchoring substrate may be made of many materials including but notlimited to; Nitinol, Titanium, steel alloys, polymers, porous materials,sponge like materials, sintered metal, etched materials, depositedmaterial, extruded material and molded materials.

Anchors

Anchors may facilitate the attachment of bone segments to the anchoringsubstrate. The anchors may mate, couple, engage, lock and otherwiseinteract with the anchoring substrate. Some of the anchors may beconfigured to engage the bone. Some of the anchors may be configured tonot engage the bone.

An anchor may have an elongated element. The elongated element mayinclude one or catch features that are configured to engage theanchoring substrate. The engagement may be occur substantiallyimmediately after penetration of the anchoring substrate by the anchor.The engagement may occur only after a predetermined length of theelongated member has passed into the anchoring substrate. Some anchorsmay lock to the anchoring substrate. Some anchors may not lock to theanchoring substrate

Catch features may be self-actuating. Catch features may be useractuated.

Anchors may have any suitable length. Anchors of different lengths maybe used in conjunction with the apparatus. The anchors can be configuredto enter and engage the anchoring substrate with an end portion of theanchor. Those anchors, after they are locked, may terminate inside theanchoring substrate. Some anchors may be configured to pass through theanchoring substrate and engage bone on an opposite side of the anchoringsubstrate. Some anchors may be configured to not engage bone on eitherside of the anchoring substrate. Example anchors include: screws,helical elements, T bar, barbed features, anchors cut from a tube, withtabbed features.

In some embodiments, anchors may be used in conjunction with buttresselements such as plates, washers, spacers and the like.

A proximal anchor may be inserted to anchor a proximal portion of theanchoring substrate to the bone. In some embodiments, the proximalanchor may be engaged to preserve tension in the anchoring substrate. Insome embodiments, the proximal anchor may be configured to adjust thetension.

Central Axis Member

In embodiments that include a central axis member, the central axismember may be used to position the apparatus, actuate one or morechanges (e.g., of expansion state or stress state) of the apparatus,move one portion of the apparatus relative to another portion of theapparatus and provide mechanical support (e.g., rigidity) to theapparatus.

In some embodiments, the apparatus may have a distal end and a proximalend. The support structure may have a distal end and a proximal end. Theanchoring substrate may have a distal end and a proximal end. Thecentral axis member may have a distal end and a proximal end. In someembodiments, the central axis member may extend proximally beyond theproximal ends of the structural support and the anchoring member. Inthose embodiments, an intermediate portion of the central axis membermay generally align with the proximal ends of the structural support andthe anchoring substrate.

The central axis member may be used to maintain rigidity of thestructural support and/or the anchoring substrate. In those embodiments,the distal end of the central axis member may be longitudinally fixed tothe distal end of the structural support and/or the anchoring substrate.The proximal end or intermediate portion of the central axis member maybe longitudinally fixed to the proximal end of the structural supportand/or the anchoring substrate.

The central axis member may be used to adjust the length of thestructural support and/or the anchoring substrate. In those embodiments,the distal end of the central axis member may be fixed to the distal endof the structural support and/or anchoring substrate. The proximal endsof the structural support and/or anchoring substrate may belongitudinally movable (whether linearly, rotationally or otherwise)with respect to the central axis member. As such, the central axismember may be used to expand the structural support or the anchoringsubstrate. The central axis member may be used to lock the apparatus inan expanded configuration. The central member may be locked in place byother elements of the apparatus.

In some embodiments, the central axis member may be used to place alower or upper limit on the longitudinal separation between distal andproximal ends of the support structure and/or anchoring substrate. Thismay be accomplished by providing detents at selected locations along thecentral axis member.

In some embodiments, the central axis member may be used to linearlydisplace the structural support relative to the anchoring substrate orthe anchoring substrate relative to the support structure. The centralaxis member may be used to linearly displace one anchoring substraterelative to another anchoring substrate. In such embodiments, thecentral axis member may be longitudinally fixed to whichever of thestructural support and the anchoring substrate that is to be movedrelative to another.

The central axis member may be used to mechanically load the structuralsupport and/or the anchoring substrate. The load may be in tension,compression or rotation. The load may be applied by suitable engagingthe central axis member with a portion of the structural support and/oranchoring substrate. The central axis member may then be loaded, forexample, at its proximal end. The central axis member may then transferthe load through the engagement with the structural support and/oranchoring structure.

Where the central axis member is longitudinally fixed to the structuralsupport and/or anchoring substrate, it may remain free to rotate. Wherethe central axis member is not longitudinally fixed, the apparatus mayinclude suitable bushings, bearings, frictional surfaces and the like topermit suitable linear displacement and/or rotation between the centralaxis member and the structural support and/or anchoring substrate.

For example, the central axis member may be longitudinally fixed to thedistal end of the structural support and rotationally fixed to theproximal end of the anchoring substrate. The distal end of the anchoringsubstrate may or may not be rotationally fixed to the distal end of thesupport structure. The central axis may thus be used in differentconfigurations to deform (e.g., wrap, fold, twist, etc.) the anchoringsubstrate. Similar configurations may be used to deform the structuralsupport.

In some embodiments, the central axis member may include or serve as ananchoring substrate. The central axis member may be removable so that itmay be removed from the apparatus after its desired effect is achieved.

The central member may be flexible or rigid. The central member may beintegral with one or both of the structural support and the anchoringsubstrate. The central axis member may include one or more cables,coils, thread, braids, extrusions, beading, rods, bundles, strands,meshes, nested elements and the like.

Apparatus Removal

The apparatus may be removable from the bone. Approaches for removal mayinclude collapsing the apparatus.

In some instances, tissue may grow into interstices of the apparatus.Energy (e.g., vibrations, ultrasonic energy, heat and the like) may becoupled into the apparatus to release the tissue. When heat energy isused, the heat may be generated from energy in any suitable form, suchas radio frequency, microwave, induction, electrical resistance, andothers.

The apparatus and methods may include removal instruments such as ahollow drill, a coring drill and the like. The apparatus may fit insideone or more of such instruments.

Bone Ingrowth

One or more surfaces of the apparatus may be coated with agents thatpromote bone ingrowth. The agents may include calcium phosphate, heattreated hydroxylapatite, Basic fibroblast growth factor (bFGF)-coatedhydroxyapatite, hydroxyapatite/tricalcium phosphate (HA/TCP), and othersuitable agents, including one or more of those listed in Table 1.

One or more surfaces of the apparatus may be coated with agents thatinhibit or prohibit bone ingrowth. Such surfaces may include impermeableand other materials such as one or more of those listed in Table 1.

Drug Delivery

One or more surfaces of the apparatus may be coated with agents that mayelute therapeutic substances such as drugs.

Complications

The apparatus and methods may include means to address complicationsthat may be associated with bone implants. One such complication isinfection. The apparatus and methods may include features thatcounteract infection. For example, such a feature may include a coating.The coating may include antibiotics such as tobramycin or othereffective antimicrobials. Another such feature may be the delivery ofheat to raise the apparatus temperature sufficiently high to killbacteria and other undesirable tissues on or near the implant.

Installation

The following is one illustrative method of installation of theapparatus in a bone that has a fracture. The procedure may be completedeither in an inpatient or an outpatient setting.

-   -   1. Provisionally reduce the fracture using standard techniques    -   2. Access the intramedullary cavity in a location that causes        minimal tissue damage to the patient and sufficient access for        the physician; proximal or distal.    -   3. Introduce a delivery catheter into the bone near the area of        the fracture. Position can be confirmed on fluoroscopy.    -   4. Deploy the structural support. A positioning aid, which may        be a central axis member, may be used. External manipulation may        be applied.    -   5. Reposition the fractured bone into its ideal healing        location. The positioning aid may then be locked into the wall        of the intramedullary cavity by deploying the anchoring        mechanism.    -   6. Deploy an anchor tensioning element (such as an anchoring        substrate) into the space inside the structural support and near        the location of the fracture.    -   7. Deploy anchors in the fracture fragments, either externally        or internally, depending on accessibility. The anchors are        driven through both the fragments and the anchoring substrate.    -   8. Confirm location of the fragments via x-ray, fluoro, or        direct visualization. Apply tension as needed to position the        fracture in the desired position with adequate pressure on the        fragment surfaces to stabilize the fracture for healing.    -   9. Lock the apparatus in place.    -   10. Disengage delivery instruments from the apparatus. Remove        the delivery instruments from the patient, and close patient.

Numerous other steps may be involved and many different sequences ofsteps may be practiced without departing from the principles of theinvention.

Materials

The apparatus and portions thereof may include any suitable materials.Table 1 lists illustrative materials that may be included in theapparatus and portions thereof.

TABLE 1 Materials Category Type Material Metals Nickel titanium alloysNitinol Stainless steel alloys 304 316L BioDur ® 108 Alloy PyrometAlloy ® CTX-909 Pyromet ® Alloy CTX-3 Pyromet ® Alloy 31 Pyromet ® AlloyCTX-1 21Cr—6Ni—9Mn Stainless 21Cr—6Ni—9Mn Stainless Pyromet Alloy 35018Cr—2Ni—12Mn Stainless Custom 630 (17Cr-4Ni) Stainless Custom 465 ®Stainless Custom 455 ® Stainless Custom 450 ® Stainless Carpenter 13-8Stainless Type 440C Stainless Cobalt chromium MP35N alloys Elgiloy L605Biodur ® Carpenter CCM alloy Titanium and titanium Ti—6Al—4V/ELI alloysTi—6Al—7Nb Ti—15Mo Tantalum Tungsten and tungsten alloys Pure PlatinumPlatinum-Iridium alloys Platinum-Nickel alloys Niobium IridiumConichrome Gold and Gold alloys Absorbable Pure Iron metals magnesiumalloys Polymers Polyetheretherketone (PEEK) polycarbonate polyolefin'spolyethylene's polyether block amides (PEBAX) nylon 6 6-6 12Polypropylene polyesters polyurethanes polytetrafluoroethylene (PTFE)Poly(phenylene sulfide) (PPS) poly(butylene terephthalate) PBTpolysulfone polyamide polyimide poly(p-phenylene oxide) PPOacrylonitrile butadiene styrene (ABS) Polystyrene Poly(methylmethacrylate) (PMMA) Polyoxymethylene (POM) Ethylene vinyl acetateStyrene acrylonitrile resin Polybutylene Membrane Silicone materialsPolyether block amides (PEBAX) Polyurethanes Silicone polyurethanecopolymers Nylon Polyethylene terephthalate (PET) Goretex ePTFE KevlarSpectra Dyneena Polyvinyl chrloride (PVC) Absorbable Poly(glycolic acid)(PGA) polymers Polylactide (PLA), Poly(ε-caprolactone), Poly(dioxanone)Poly(lactide-co-glycolide) Radiopaque Barium sulfate materials Bismuthsubcarbonate Biomaterials Collagen Bovine, porcine, ovine, amnionmembrane Bone growth Demineralized bone matrix factors Bone morphogenicproteins (BMP) Calcium phosphate Heat-treated hydroxylapapatite Basicfibroblast growth factor (bFGF)-coated hydroxyapaptiteHydroxyapaptite/tricalcium phosphate (HA/TCP Anti- microbial Coatings

The apparatus may be provided as a kit that may include one or more of astructural support, an anchoring substrate, a central axis member, ananchor, a delivery instrument and associated items.

Apparatus and methods in accordance with the invention will now bedescribed in connection with the FIGS. The FIGS. show illustrativefeatures of apparatus and methods in accordance with the principles ofthe invention. The features are illustrated in the context of selectedembodiments. It will be understood that features shown in connectionwith one of the embodiments may be practiced in accordance with theprinciples of the invention along with features shown in connection withanother of the embodiments.

Apparatus and methods described herein are illustrative. Apparatus andmethods of the invention may involve some or all of the features of theillustrative apparatus and/or some or all of the steps of theillustrative methods. The steps of the methods may be performed in anorder other than the order shown and described herein. Some embodimentsmay omit steps shown and described in connection with the illustrativemethods. Some embodiments may include steps that are not shown anddescribed in connection with the illustrative methods.

Illustrative embodiments will now be described with reference to theaccompanying drawings, which form a part hereof.

The apparatus and methods of the invention will be described inconnection with embodiments and features of an illustrative bone repairdevice and associated hardware and instrumentation. The device andassociated hardware and instruments will be described now with referenceto the FIGS. It is to be understood that other embodiments may beutilized and structural, functional and procedural modifications may bemade without departing from the scope and spirit of the presentinvention.

FIG. 1 shows illustrative device 100 implanted in bone B, which isillustrated as a radius. Bone B includes bone portions P_(B), P_(h) andP_(a) in distal end D. Bone segment PB is the largest portion of bone B.Bone segment Ph is a head portion. Bone segments P_(h) and P_(a) includearticular surface AS. Bone portions P_(B), P_(h) and P_(a) are separatedor partially separated along fractures F_(a) and F_(h). Fracture F_(a)transects articular surface AS. Fracture F_(h) transects head H.

It will be appreciated that bone portions P_(B), P_(h) and P_(a) definean illustrative fracture in bone B. Device 100 may be used to treatfractures that have a greater or lesser number of bone portions. Thebone portions may have different shapes, orientations and sizes fromthose shown in FIG. 1. It will be appreciated also that the fractureshown in FIG. 1 is illustrated as a fracture near the end of a longbone, but device 100 may be used to treat fractures in other portions oflong bones, such as the midshaft, and in bones that may be identified asbeing other than long bones, e.g., vertebrae.

Device 100 is elongated along its longitudinal axis L_(D) (in which Dindicates device). Device 100 is in intramedullary space IS of bone B.Distal end 102 of device 100 is in epiphyseal region E of bone B.Proximal end 104 is in or adjacent diaphyseal region D of bone B.Portions of device 100 that are between distal end 102 and proximal end104 are in metaphyseal region M of bone B.

Device 100 may include structural cage 105. Structural cage 105 mayinclude support members 106. Support members 106 may extend from cagebase 108 to distal hub 110. (The direction extending from cage base 108will be referred to as the “distal direction.” The opposite directionwill be referred to as the “proximal direction.” “Distal,” relative to“proximal,” generally means the leading end of apparatus that isinserted, or is to be inserted, in the body.) The distance along axis LDbetween cage base 108 and distal hub 110 may be adjusted to change theshape of support members 106.

When cage base 108 is maximally spaced apart from distal hub 110,structural cage 105 is in a compressed state. When cage base 108 anddistal hub 110 are pushed or drawn together, structural members 106 aredeflected radially outward along radial direction R_(D) (in which “D”indicates device). In this way, structural cage 105 may expand. Device100 is shown in an expanded state. In some embodiments, structuralmembers 106 and anchor substrate 124 may self-expand radially. This maydraw base 108 and distal hub 110 together longitudinally.

Structural cage 105 may be used to provide support to bone portionsP_(B), P_(a) and P_(h). The support may include aligning and stabilizingbone segments P_(B), P_(a) and P_(h) during reduction and/or healing.The support may be subchondral support. Structural cage 105 may be usedto provide load resistance to bone B during healing.

Device 100 may include anchoring substrate 112. Substrate 112 may beengaged by anchors such as 114 and 116. Anchor 114 fastens bone segmentPh to substrate 112. Anchor 116 fastens bone segment Pa to substrate112. The anchors may engage substrate 112 in a wide range of positions.The anchors may engage substrate 112 from a wide range of angles. Eachof the anchors may apply a force to its respective bone portion. Theforce may be oriented to appropriately position the bone portions forhealing. The force may be directed at least in part toward axis LD. Theforce may be considered an inward force (at least partially in direction−R_(D)). Structural cage 105 may apply to the bone portions a force thatis directed at least in part away from axis L_(D). The force fromstructural cage 105 may be considered an outward force (at leastpartially in direction R_(D)).

Anchors 114 and 116 are illustrated as threaded screws, but any suitableanchors may be used.

The anchors, anchoring substrate and support structural cage may thus beused in concert to select for each bone portion one or more of a desiredposition, orientation and force. One or both of the position andorientation may be selected by appropriate selection of anchor size,anchor position, anchor tension, structural cage size, and supportmember configuration and position. Because the position and orientationmay be selected, the bone portions may be appropriately aligned relativeto each other.

Device 100 may include stem 128. Stem 128 may extend in the proximaldirection from cage base 108. Stem 128 may include stem anchoringsubstrate 118 and proximal base 120. Stem anchoring substrate 118 maysupport proximal base 120. Anchor 122 may fasten stem 128 to bone Bportion P_(B). Anchor 122 may be engaged such that it applieslongitudinal and/or rotational forces to device 100. Anchor 122 may beengaged such that it applies a radial force to device 100. The radialforce may induce or counteract bending of device 100 along axis L_(D).Anchor 122 may apply a resistive longitudinal force to device 100. Theresistive longitudinal force may resist forces applied to device 100 bydistal anchors 114 and 116.

Proximal base 120 may support device retention feature 122. Deviceretention member 126 may be used to engage device 100 for insertion andmanipulation. A device manipulator (not shown) may be used inconjunction with device retention member 126 to draw device 100 in theproximal direction.

Device may include illustrative central member hub 130. Central memberhub 130 may be used to recapture and remove device 100 after deployment.

Drawing device 100 in the proximal direction may adjust forces (tensile,compressive or both) between bone portions P_(a), P_(h) and P_(B).Drawing device 100 in the proximal direction may adjust the orientationand position of bone portions P_(a) with respect to P_(B). In someembodiments, anchor 122 may be used to retain the compressive forcesafter device 100 is drawn in the proximal direction.

Device 100 may include central axis member 124. Central axis member 124may extend from distal hub 110, through cage base 108 and throughproximal base 120 into intramedullary space IS of bone B. Central axismember 124 may be used to effect expansion of structural cage 105. Someembodiments may not include central axis member 124. (In someembodiments, anchoring substrate 112 may be drawn proximally relative tostructural cage 105 to adjust the tension while maintaining the positionand support of the bone segments.)

In some embodiments, central axis member 124 may be used to expandstructural cage 105 by applying tension between hub 100 and cage base108 and/or 120. In some embodiments, this may be done by applyingsimultaneously a proximally directed force to central axis member 124and a distally directed force to cage base 108. In some embodiments,central axis member may be rotatably connected to hub 110 and threadedthrough cage base 108. In those embodiments, structural cage 105 may beexpanded by rotating central axis member 124. In some embodiments,structural cage 105 may be self-expanding.

The final expanded shape may be designed into the structure ofstructural cage 105. The final expanded shape may be limited by thespace available in the cavity. The expansion may be elastic and may bebased on a spring material that returns to a predetermined shape.

Device 100 in its compressed state may be delivered into the bodythrough a small access incision along the mid shaft section bone (D, inFIG. 1) in an area where soft tissue disruption can be minimized.

FIG. 1A shows device 100 in isometric view. Structural cage 105 includessupport members 106. Support members 106 may expand or contract alongdirection R_(D) based on relative positioning of cage base 108 and hub110 along device axis L_(D). Support cage 105 may be contracted forintroduction into intramedullary space IS.

Support cage 105 is illustrated as having six support members 106. Itwill be appreciated that any suitable numbers of support members may beused. for example, support cage 105 may have a number of support members106 in the range of 2-40 or more than 40.

Support members 106 are illustrated as having a rectangularcross-sectional shape. It will be appreciated that support members 106may have any suitable cross-sectional shape. For example, thecross-sectional shape may be round, square, braided, stranded orprofiled. Support cage 105 may include support members that havedifferent cross-sectional shapes, dimensions or material properties.When support members have different shapes, dimensions or materialproperties, support cage 105 may undergo non-radial deformation. Suchdeformation may be helpful for conforming device 100 to the inside ofbone B (including bone segments P_(a), P_(h) and P_(B)).

Support members 106 are illustrated as being joined at cage base 108 andhub 110. The ends of the members are shown joined at both ends. In someembodiments, support members 106 may have one or more free or partiallyfree ends.

Support members 106 may be cut of a single tube or could be madeindependently and then joined.

Anchoring substrate 112 is present inside structural cage 105. Anchoringsubstrate 112 may have a collapsed state and an expanded state. Thecollapsed state may be used for delivery. The expanded state may be usedfor deployment and fracture repair.

In some embodiments, anchoring substrate 112 may include a laser-cutstructure. Anchoring substrate 112 may be constructed so as to engagewith an anchor such as 114 (shown in FIG. 1) and hold the anchor under amechanical load. In some embodiments, anchoring substrate 112 may beaffixed to support cage 105. Anchoring substrate 112 may be affixed toone or more of hub 110, one or more portions of support members 106,central axis member 124, cage base 108 and proximal base 120.

In some embodiments, anchoring substrate 112 may not be affixed todevice 100 (although it may be retained by support cage 105). Such lackof attachment may facilitate adjustment of the tension and loading ofbone segments.

FIG. 1B is a cross-sectional view taken along lines 1B-1B (shown in FIG.1A). FIG. 1B shows central axis member 124 running from hub 110 (notshown) through anchoring substrate base 132 (which is concentricallywithin cage base 108), stem 128, proximal base 120 and device retentionmember 126.

Central member hub 130 protrudes proximally from device retention member126. Central member hub 130 may be configured to be engaged to adjust orcontrol tension and or rotation of central member 124. Manipulation ofcentral member hub 130 may facilitate delivery and expansion ofstructural cage 105, and or anchor substrate 112. Central member hub 130may maintain tension between distal and proximal ends of structural cage105 or anchoring substrate 112.

Device retention member 126 may be used to in connection with delivery,manipulation and or removal of device 100.

Stop 134 on central axis member 124 may be drawn in proximal directionD_(P) by pulling central member hub 130 in direction D_(P) relative tostem 128. In some embodiments, this may be accomplished by pushingdevice retention member 126 distally (−D_(P)) while pulling centralmember hub 130 proximally. The pushing and pulling may be accomplishedusing apparatus and methods shown and described herein or known graspingdevice instruments.

Stop 134 will urge anchoring substrate base 108 in direction D_(P).Anchoring substrate base 108 will then draw anchoring substrate 112 indirection D_(P). Motion of anchoring substrate 112 in direction DP willapply force to anchors 114 and 116. The force may have a distalcomponent and a radially inward (−R_(D)) component. The force may thuscompress bone segments Pa and Ph against bone segment P_(B) (shown inFIG. 1).

Stop 134 may transfer longitudinal force from device retention member126 in a proximal direction to anchor substrate 112 through the couplingmechanism between device retention member 126, proximal base 120 andcentral member hub 130. Alternatively central axis member 124 may becoupled mechanically to cage base 108 by a ratchet, screw or othersuitable mechanism.

FIG. 1C shows a view taken along lines 1C-1C (shown in FIG. 1A). FIG. 1Cshows expanded support cage 105 (including hub 110) and expandedanchoring substrate 112. Locking anchor 122 is also shown.

One or more of the surfaces or elements of device 100 may include acoating. The coating may include an agent. The agent may provide a bonegrowth promotion agent, a bone growth inhibition or prohibition agent, adrug eluting agent or any other suitable agent.

FIG. 2 shows illustrative skeleton S. Skeleton S includes illustrativebones S_(i) in which device 100 (shown in FIG. 1) may be used as shownand described in connection with bone B (shown in FIG. 1). Table 2includes a partial list of bones S_(i).

TABLE 2 Bones S_(i). Reference numeral in Bone FIG. 2 Distal Radius S₀Humerus S₁ Proximal Radius and Ulna (Elbow) S₂ Metacarpals S₃ ClavicleS₄ Ribs S₅ Vertebrae S₆ Ulna S₇ Hip S₈ Femur S₉ Tibia S₁₀ Fibula S₁₁Metatarsals S₁₂

FIG. 3 schematically shows anatomy of bone B (shown in FIG. 1).Anatomical features of bone B are listed in Table 3. Apparatus andmethods in accordance with the principles of the invention may involveone or more of the anatomical features shown in Table 3. Features ofbone B may be described in reference to bone axis L_(B) (in which Bindicates bone) and radius R_(B) (in which B indicates bone).

TABLE 3 Anatomical features of some of the bone types that may betreated by the apparatus and methods. Reference numeral Anatomicalfeature in FIG. 3 Articular surface B₀ Cancellous, spongy or trabecularbone B₁ Medullary cavity B₂ Cortical or dense bone B₃ Periosteum B₄Proximal articular surface B₅ Diaphysis or midshaft B₆ Metaphysis or endregion B₇ Epiphysis B₈ Articular surface B₉

The terms “end-bone” and “end-bone fracture” may be used to refer tofractures that occur in the epiphyseal or metaphyseal region of longbones. Such fractures include peri-articular and intra-articularfractures.

FIG. 4 shows portion 400 of an illustrative surgical environment inwhich a fracture in bone B may be diagnosed and treated. Patient P maybe sedated appropriately. A limb nerve block may be administered. Apressure cuff may be used to maintain limb Q in a relatively blood-freestate. Limb Q may be supported by procedure table 402 and any otherappropriate supports to manage the position of bone B during surgery.Environment 400 may include imaging system 404.

FIG. 5 shows illustrative therapeutic scenario 500. In scenario 500,manual traction techniques are applied to reestablish anatomic reductionin fracture F_(p) in bone B.

Provisional or temporary reduction is often undertaken in fracturerepair to restore bone segments to their normal positions before theyare anchored.

When the number of bone segments is small and/or the dislocation of thebone segments is modest, closed reduction techniques may be employed.Closed reduction does not include incisions and utilizes manual tractionby one or more physicians. The physicians will utilize differenttension, compression, and bending motions to reestablishing normal bonesegment positioning. A physician or assistant may maintain the normalbone segment positions during an implant procedure.

For more displaced fracture patterns, a limited open reduction can beutilized. K-Wires, external probes, and special clamps can be employedfor the provisional reduction. Small incisions can be made allowing theprobes and clamps to aid in repositioning the fracture segments. Oncethe bone segments are in position k-wires can be utilized to maintainthe reduction. K-Wires are approximately 1-2 mm in diameter metallicwires that can be driven across fracture lines to provide temporarysupport. The k-wires may be positioned and then removed strategically tofacilitate the procedure in a way that reduces interference with bonecavity preparation or implant deployment.

FIG. 6 shows illustrative sheath 600. Hollow sheath 600 is shownentering intramedullary space IS of bone B. Sheath 600 may include lumen610. Lumen 610 may provide access to intramedullary space IS. Sheath 600enters intramedullary space IS at position 602. Position 602 may be indiaphyseal section D of bone B. Position 602 may be selected to minimizesoft tissue damage. Near position 602, a small incision may be made inthe soft tissue (not shown). The tissue may be displaced to reveal bonesurface BS.

A standard orthopaedic drill instrument may be used to create accesshole 604 in bone B. Axis hole 604 may be drilled along axis L_(h). AxisL_(h) may form an angle A with bone axis L_(B). Angle A may be an acuteangle.

Hole 604 may be similar to commonly drilled bone access holes. Hole 604may be sufficiently small that hole 604 does not cause stress risers atposition 602. Distal end 606 of sheath 600 may be advanced, throughintramedullary canal IC, into metaphyseal region M of bone B. Proximalend 608 of sheath 600 may be positioned in hole 604. Distal end 606 maybe disposed in any portion of intramedullary space IS, such as in theend-bone.

Sheath 600 may be a thin-walled flexible cannula. Sheath 600 may besimilar to the cannulas that are commonly used in minimally invasive orpercutaneous interventional procedures elsewhere in the body. Sheath 600may be made of rigid metal that is shaped to promote access tointramedullary space IS.

FIG. 7 shows illustrative intramedullary space reamer 700. Reamer 700may be expandable and contractible. Reamer 700 may in a contracted statebe inserted in proximal end 608 of sheath 600 (shown in FIG. 6). Reamershaft 702 may be used to advance reamer 700 through lumen 610 intometaphyseal region M of bone B. Reamer 700 may have suitable features ator about surface 704 for removing undesirable tissue, such as cancellousbone, from the end-bone. Reamer shaft 702 may rotate reamer surface 704about, and translate it along, bone axis L as appropriate to prepare theend-bone for further treatment.

In some embodiments, the use of reamer 700 may be consistent withprocedures that are used in the implantation of intramedullary nails.Such procedures include the application of one or more of ultrasonicenergy, vibration, RF energy, pressure, rotation, water jetting, suctionand other suitable mechanisms to remove the undesirable tissue. In someembodiments, reamer 700 may have one or more of the following features:expansion, fixed size (non-expanding), uni-directional reaming,multi-directional reaming, rigid reamer shaft 702, flexible reamer shaft702 and steerability.

FIG. 8 shows a stage in the delivery of device 100 to end-bone of boneB. In FIG. 8, device delivery apparatus 800 is engaged with deviceretention element 126 at the proximal end of device 100. Shaft 802 maycontrol positioning and rotation of device delivery apparatus 800.Delivery apparatus 800 may include a keyed grasper for engagement anddisengagement of portions of device 100 (shown in FIG. 1). Device 100 isin a compressed state. Device 100 is positioned within lumen 610 ofsheath 600. Distal hub 110 of device 100 is in epiphyseal region E ofbone B. Support members 106 and stem 128 are also shown within lumen610.

FIG. 9 shows a subsequent step in the delivery of device 100 to theend-bone of bone B. In FIG. 9, device delivery apparatus 800 has moveddevice 100 distally out of sheath 600. Structural cage 105 has beenexpanded in the end-bone. In the example illustrated, the end-bone spansfrom the bone segments to midshaft D of bone B intramedullary space IS.

FIG. 9 also shows proximal delivery apparatus controller 900. Controller900 may include handle 902, trigger mechanism 904 and set screw 906.Handle 902 may be used to apply, via shaft 802, the forces that arenecessary to position and expand device 100. Trigger mechanism 904 maybe used to engage or disengage device retention member 126.

FIG. 10 shows the fastening of bone segment P_(a) to anchoring substrate112. A small incision may be made in skin K in an optimal location.Then, a small pilot hole may be made in the bone segment P_(a).Provisional reduction may be maintained by assistant's hand 1002,tong/clamp type instruments, k-wires or other known methods. Support1004 may be provided to position bone segments P_(a), P_(h) and P_(B)for the insertion of anchor 116. Then, instrument 1000 may be used todrive anchor 116 through bone segment P_(a). Instrument 1000 may be ascrewdriver or other suitable instrument.

FIG. 11 shows anchor 114 fastening bone segment Ph to anchoringsubstrate 112. Device 100 may be stabilized in bone B using devicedelivery apparatus 800.

FIG. 12 shows tensioning device 100 in intramedullary space IS of boneB. Anchors 114 and 116 have been completely or almost completely driveninto bone segments P_(h) and P_(a), respectively. Anchors 114 and 116are secured inside bone B by anchoring substrate 112. The inward forcesapplied by anchors 114 and 116, in concert with anchoring substrate 112,and the outward forces applied by support members 106 of structural cage105, have brought bone segments P_(h) and P_(a) into alignment alongfracture F_(a) and have closed fracture F_(a). The torque (applied tothe anchors), angle and positioning of anchors 114 and 116 may beselected to provide a desired contact force between bone segments P_(h)and P_(a) along fracture F_(a). The anchors may lock to anchor substrate112 to prevent unintentional removal.

Fracture F_(h) remains open by separation amount Δf, which separatesP_(a) and P_(h) from P_(B), the main segment of bone B. Intersegmentcompression of bone segments P_(a), P_(h) and P_(B) may be providedusing one or more of device 100, device delivery apparatus 800 anddelivery apparatus controller 900. The compression may help reduce oreliminate Δf. The compression may promote healing. The compression mayprovide stability to the bone segments in rotation and bending.

In some embodiments, the compression may be provided by drawing device100 in proximal direction D_(P), substantially. Length T of device 100may be fixed, at least temporarily. For example, length T may be heldfixed using a mechanical relationship of central axis member 124 to cagebase 108 and hub 110. Device 100 may then be drawn in direction D_(P) bydevice delivery apparatus 800. Device delivery apparatus 800 may bedrawn in direction D_(P) by shaft 802. Shaft 802 may be drawn throughlumen 610 using delivery apparatus controller 900.

Device 900 may include a mechanism that may be activated by a trigger orlever such as 904 or 906. Shaft 802 may be drawn by drawing deliveryapparatus controller 900 in direction D_(h) along axis L_(h). Distal end606 of sheath 600, to the extent that it remains in intramedullary spaceIS, will travel generally along direction D_(P) and draw device 100 inthat direction via device delivery apparatus 800.

In some embodiments, length T may be allowed to extend when device 100is drawn in direction D_(P). Hub 110 may be substantially retained inposition relative to bone segment P_(a). Cage base 108 may be allowed tobe displaced in direction D_(P). This may reduce radius R_(D) ofstructural cage 105. When the radius of structural cage 105 is reduced,radially outward forces on bone may be reduced, canceled or reversed.

As the length of device 100 is increased while its radius decreases,device 100 may collapse partially or completely to its delivered state.Depending on the diameter of intramedullary space IS of bone, B suchcontraction may be desirable to obtain proper placement of the bonesegments. After proper bone segment position is obtained, the radialdiameter can be adjusted to achieve the desired shape and radial force.This condition can then be maintained by locking central axis member 124at distal and proximal ends of device 100.

In some embodiments, a proximal portion of anchoring substrate 112 maybe drawn in direction D_(P). This may draw anchors such as 114 and 116in direction D_(P) and direction −R_(B). Anchoring substrate 112 may bedrawn in direction D_(P) with a force that is greater, lesser or equalto that by which structural cage 105 is drawn in direction D_(P).

In some embodiments, a physician may assess and, if appropriate, adjustone or more of segments Pa, Ph and PB to achieve a desired alignment.The assessment may be performed using fluoroscopic imaging, for example,using imaging system 404 (shown in FIG. 4). The assessment may be doneunder direct visualization during a full surgical cut down procedure.

FIG. 13 shows the application of force Φ in direction D_(P). Force Φ isapplied to device 100 at device retention member 126 by device deliveryapparatus 800. Δf of fracture F has been stabilized, reduced orsubstantially eliminated. Anchor 122 is now inserted through bone B intostem 128. Anchor 122 may retain proximal portion of device 100 at ornear an axial position along bone axis L_(B). Anchor 122 may preventdevice 100 from rotating about bone axis L_(B). Anchor 122 may preservethe intersegment compression between bone segments P_(a), P_(h) andP_(B). More generally, anchor 122 may preserve one or more of a desiredposition, orientation and state of stress for each of the individualbone segments. Anchor 122 may carry all or some of the load. Frictionbetween structural cage 105 and other portions of device 100 may bearsome of the load.

In some embodiments, the role of anchor 122 may be fulfilled by severalanchors that may be used to lock device 100 in bone B while preservingthe compression. Proximal anchors may gain purchase from both sides ofthe bone or just through one side. The angle of the anchors may rangefrom near parallel to axis L_(D) to perpendicular to axis L_(D).

FIG. 14 shows the release of device retention member 126 (by devicedelivery apparatus 800, which in FIG. 14 has been withdrawn into sheath600). Device retention member 126 is shown as a simple keyed ball endthat may be retained with a known grasping instrument. Other types ofretention mechanisms are also considered and envisioned with respect toembodiments of the invention including but not limited to; threaded,socket, pinned, snap, collet, and any other mechanism known in the art.

FIG. 15 shows device in a final implanted state with sheath 600 (notshown) removed from intramedullary space IS of bone B. Device 100retains segments P_(a), P_(h) and P_(B) in compression relative to eachother. Fractures F_(a) and F_(h) are reduced.

FIG. 16 shows that device 100 may be recaptured in intramedullary spaceIS and removed from bone B. Illustrative delivery/recapture device 1600may engage central member hub 130. Engagement member 1602 at the distalend of delivery/recapture device 1600 may slide over central member hub130 and engage device retention member 126. Support members 106 ofsupport cage 105 may contract as they are drawn into sheath 600.

FIG. 17 shows closure assembly 1700 that may be used to close hole 604and preserve access to device 100 in bone B. Closure assembly 1700 mayinclude plug 1702. Plug 1702 may seal or substantially seal hole 604.Plug 1702 may cap cannula 1704. Cannula 1704 may provide access tocentral member hub 130 (not shown) and device retention member 126 (notshown). Flange 1706 may engage with one or both of central member hub130 (not shown) and device retention member 126 (not shown). Flange 1706may be affixed to sheath 1704. Cannula 1704 may be configured to applyforce to device 100 to adjust tension or radial diameter in structuralcage 105 or anchoring substrate 112.

In some embodiments, some or all of the functionality provided bycannula 1704 may be provided by a cable or a shaft (not shown). In someof those embodiments, plug 1702 may be a threaded or ribbed plug, or ascrew-like plug, that is linked to the cable.

Cap 1702 may be removed to insert an instrument such as engagementmember 1602 to recapture device 100 in a manner such as that shown inFIG. 16.

FIG. 18 shows illustrative delivery/recapture member 1802, which in someembodiments may be an alternative to device retention member 126 in adevice such as 100 (shown in FIG. 1). Delivery/recapture member 1802 maybe formed from a tube. Notch 1810 may be cut into the tube. Anyappropriate number of notches such as 1810 may be present indelivery/recapture member 1802. Delivery/recapture member 1802 mayinclude ferrule 1804, which may be affixed to proximal end 1806 ofdevice stem 1806. Stem 1806 may correspond to stem 128 of device 100(shown in FIG. 1).

Recapture instrument 1812 may include one or more blades such as blade1814. Recapture instrument 1812 and blade 1814 may be cut from a tube tomatch delivery/recapture member 1802 and notch 1810, respectively.Recapture instrument 1812 may be delivered through a sheath such as 600(shown in FIG. 6) into an intramedullary space to retrieve a deviceattached to stem 1808.

Recapture instrument 1812 may be aligned with delivery/recapture member1802. Blade 1814 may be inserted into cut-out 1816 in delivery/recapturemember 1802. Recapture instrument 1812 may be rotated such that blade1814 moves into notch 1810. Recapture instrument 1812 may thus engagedelivery/recapture member 1802 to pull the device in proximal directionD_(P). Blade 1814 and delivery/recapture member 1802 may bend radiallyout of plane from each other to disengage. The bending may be achievedby bending or releasing a spring-like mechanism or by plasticdeformation of recapture instrument 1812.

FIG. 19 shows illustrative device 1900. Device 1900 may have featuresthat function like some or all of the corresponding features of device100 (shown in FIG. 1). For example, device 1900 may include supports1906 that form cage 1905. Cage 1905 may include cage base 1908.Anchoring substrate base 1932 may be present concentrically within cagebase 1908. Device retention member 1926 may extend proximally fromanchoring substrate base 1932. Device 1900 does not include a stem suchas stem 128. Proximal anchor 1932 may be used to engage a bone such as B(shown in FIG. 1) with the proximal end of anchoring substrate 1912.

FIG. 20 shows a cross-section of device 1900 taken along lines 20-20(shown in FIG. 19). Illustrative central axis member 1924 is fixed athub 1910 of support cage 1905. Central axis member 1924 may includeflange 1902. Flange 1902 may be mechanically locked into chamber 1904 ofdevice retention member 1926. In some embodiments, central axis member1924 may be moved axially until flange 1902 snaps into chamber 1904.This may lock-in central axis member 1924 between proximal end 1920 anddistal end 1922 of device 1900 and thus provide axial tension that maysupport the radial stiffness of device 1900. Central axis member 1924may distribute tension that may be applied to device retention member1926 between proximal end 1920 and distal end 1922 of device 1900.

In some embodiments, device 1900 may be expanded before deployment (asin an open reduction). In such embodiments, structural support 1905 andanchoring substrate 1932 may be longitudinally fixed with respect toeach other at proximal end 1920 and distal end 1922 of device 1900.

FIG. 21 shows, in cross-section, illustrative ratchet mechanism 2100.Ratchet mechanism 2100 may be used to preserve tension in a central axismember such as 124 (shown in FIG. 1). A portion of such a central axismember may be embodied as ribbed member 2102. Ribbed member 2102 may bedrawn through tabbed member 2104 in proximal direction D_(P). Rib 2106may be drawn in direction DP by deflecting annular tab 2108. After rib2106 passes annular tab 2108, annular tab 2108 moves back to its restposition (as shown) and prevents rib 2106 from moving back to a positionthat is distal to annular tab 2108.

Ratchet mechanism 2100 may be provided in or about an anchoringsubstrate base such as 132, in or about a stem such as 128, in or abouta proximal base such 120 or in or about device retention member 126 (allshown in FIG. 1). Tabbed member 2104 may be longitudinally fixed to thedevice. The central axis member may be provided over a portion of itslength with ribbed member 2102. The central axis member may thus bedrawn in proximal direction D_(P) and locked in place by annular tabs2108. This may preserve tension in portions of the central axis memberthat are distal of tabs 2108.

Ratchet features may take on any shape or form to facilitate one-waylocking. The one-way locking may be permanent or releasable. In someembodiments, tabs 2104 may be releasable so that ribbed member 2102 maybe adjusted in either longitudinal direction.

The ratchet features may be incorporated into the apparatus. The ratchetfeatures may be integral to one or more portions of the apparatus. Forexample, device stems, such as those shown in FIG. 25 may includecomplementary ratchet features so that when the stems are in aconcentric relationship, the inner stem can move in only one direction.

FIG. 22 shows an end view of ratchet mechanism 2100 (shown in crosssection, along lines 21-21, in FIG. 21).

FIG. 23 shows illustrative stacking rings 2300 that may form all or aportion of a central axis member such as 124 (shown in FIG. 1). Therings are shown as one continuous helix. In some embodiments, the ringsmay be individual annular rings with stacking features similar tohelical stacking rings 2300.

FIG. 24 is a cross-sectional view taken along lines 24-24. The helicalrings form S-links that interlock with each other under longitudinalloading of the stack—either in compression or in tension. The shape ofstacking rings 2300 is such that may they wedge together in eithercompression or tension and effectively reduce the mechanical degree offreedom to move relative to each other. All or a portion of a centralaxis member such as 124 (shown in FIG. 1) may include a segment ofhelical rings 2300. When loaded in tension or compression, the centralaxis member may become straight and rigid. The straightness and rigiditymay increase the amount of load, whether in tension, compression, orbending, that may be supported by a device such as 100.

FIG. 25 shows illustrative device 2500, which is in accordance with theprinciples of the invention. Device 2500 may include central axis member2502. Central axis member 2502 may include cellular body 2504. Centralaxis member 2502 may include device retention member 2506.

Device 2500 may include intermediate member 2507. Intermediate member2507 may include anchoring substrate 2506. Anchoring substrate 2506 isshown in an expanded state. Intermediate member 2507 may include stem2508. Stem 2508 may be continuous with anchoring substrate 2506. Necksupport 2510 may provide structural support and connection betweenanchoring substrate 2506 and stem 2508. When anchoring substrate 2506 isin a contracted state, intermediate member 2507 may contract to adiameter substantially equivalent to that of stem 2508. Device retentionmember 2512 may be present at the end of stem 2508.

Device 2500 may include outer member 2514. Outer member 2514 may includesupport cage 2516. Support cage 2516 is shown in an expanded state.Outer member 2514 may include stem 2518. Stem 2518 may be continuouswith support cage 2516. Neck support 2520 may provide structural supportand connection between support cage 2516 and stem 2518. When supportcage 2516 is in a contracted state, outer member 2514 may contract to adiameter substantially equivalent to that of stem 2528. Device retentionmember 2522 may be present at the end of stem 2518.

FIG. 25 shows inner member 2502, intermediate member 2507 and outermember 2514 separate from each other, but they may be used together toperform some or all of the functions of device 100 (shown in FIG. 1).Inner member 2502, intermediate member 2507 and outer member 2514 mayrespectively correspond, at least in part, to a central axis member suchas 124, an anchoring substrate such as 112 and a support cage such as105 (shown in FIG. 1).

One or both of intermediate member 2507 and outer member 2514 may beself-expanding. One or both of intermediate member 2507 and outer member2514 may be expandable by mechanical actuation.

FIG. 26 shows device 2500 in an assembled and expanded configuration.Inner member 2502 extends longitudinally inside intermediate member2507. Intermediate member 2507 extends longitudinally inside outermember 2514. Device retention members 2506, 2512 and 2522 extend fromthe proximal end of device 2500. Proximal anchor 2524 transects stems2518 (of outer member 2514) and 2508 (of intermediate member 2507, notshown) and cellular body 2504 of inner member 2502.

In the absence of proximal anchor 2524, inner member 2502, intermediatemember 2507 and outer member 2514 may be moved longitudinally, withrespect to each other, along axis LD. The relative motion may be inducedby delivery/recapture instruments engaged with each of the deviceretention members. For example, a delivery/recapture instrument such as1812 (shown in FIG. 18) may be provided for each of the device retentionmembers. The three recapture instruments may be coaxial with each other.

In some embodiments, one or more of inner member 2502, intermediatemember 2507 and outer member 2514 may be coupled to each other at thedistal end of device 2500 to obtain an appropriate response to theapplication of longitudinal and rotational forces that may be applied toone or more of inner member 2502, intermediate member 2507 and outermember 2514. The response may be modified by coupling one or more ofinner member 2502, intermediate member 2507 and outer member 2514 toeach other at a more proximal portion of device 2500.

Inner member 2502, intermediate member 2507 and outer member 2514 areshown having closed distal ends. In some embodiments, one or more of themembers may have an open or free distal end.

In some embodiments of the invention, device 2500 may not include innermember 2502. Those embodiments may include intermediate member 2507 andouter member 2514. In some embodiments, device 2500 may include two ormore intermediate members 2507 and or two or more outer members 2514.For example, in some embodiments, device 2500 may include inner member2502, intermediate member 2507, outer member 2514 and, external to outermember 2514, a fourth member (not shown), that is similar tointermediate member 2507. In some embodiments, device 2500 may include,internal to the other members, a fourth member (not shown) that issimilar to outer member 2514. The device may include, radially outsidethe fourth member, intermediate member 2507, a fifth member (not shown)that is similar to intermediate member 2507, and outer member 2514.

FIG. 27 shows outer member 2514 in a contracted state. In someembodiments, outer member 2514 may have bending flexibility alonglongitudinal axis L_(D), as shown in FIG. 27. Inner member 2502 andintermediate member 2507 may also have bending flexibility alonglongitudinal axis LD. The flexibility may facilitate access intointramedullary space IS of bone B. In some embodiments, the contractedconfiguration of device 2500 may include curvature to facilitate accessinto intramedullary space IS of bone B.

FIG. 28A shows illustrative two-member fracture repair device 2800.Device 2800 is shown in a contracted state. Device 2800 may beself-expanding or balloon-expanding. Device 2800 may include cage member2802 and anchoring member (inside cage member 2802) 2804.

Cage member 2804 may include support cage 2806. Support cage 2806 mayinclude support members 2810. Support members 2810 may terminate atdistal hub 2812 and cage base 2814. Cage stem 2816 may extend proximallyfrom cage base 2814. Cage stem 2816 may terminate at device retentionmember 2818. Support cage 2806 may be expanded in an intramedullaryspace IS (shown in FIG. 1).

Anchoring member 2804 may include anchoring substrate 2820. Anchoringmember 2804 may include anchoring stem 2822 and device retention member2824. In the contracted state, anchoring member 2804 may slidelongitudinally within cage member 2804.

FIG. 28B shows device 2800 in the expanded state. Support cage 2806 isexpanded. Anchoring substrate 2820 is expanded.

FIG. 28C shows is a partial cross section, taken along lines 28C-28C(shown in FIG. 28B) of device 2800 in the expanded state. Anchoringsubstrate 2820 is present inside support cage 2806. Anchoring stem 2822is present inside cage stem 2816. Device retention member 2824 ispresent inside cage stem 2816.

Distal anchors may attach bone segments to anchoring substrate 2820.Device retention members 2824 and 2818 may be translated longitudinally,together or relative to each other, to apply force to the anchors inproximal direction D_(P) and inward radial direction −R_(D).

Device 2800 may be self-expanding. Device 2800 may be plasticallydeformable and be expanded by an outside force. One or more elements ofdevice 2800 may be made from a unitary member such as a laser cut tube.One or more elements of device 2800 may be made individually and laterassembled.

FIG. 29 shows illustrative bone fracture repair device 2900, which is inaccordance with the principles of the invention. Device 2900 is showninserted inside humerus B_(H). Humerus B_(H) includes fractures F₁ andF₂, which separate bone segments P₁ and P₂, respectively, from bonesegment P. Device 2900 may include support cage 2902. Device 2900 mayinclude anchoring substrate 2904. Support cage 2902 and anchoringsubstrate 2906 are shown in an expanded state. Device 2900 may includecentral axis member 2924.

Anchor 2907 and 2908 may be present to anchor bone segments P₁ and P₂,respectively, to anchoring substrate 2904.

Device 2900 may include relative displacement actuator 2910. Actuator2910 may effect relative displacement of support cage 2902, anchoringsupport 2904 and central member 2906. During delivery of device 2900 tointermedullary space IS, device 2900 may be in a contracted state (notshown). During deployment, device 2900 may be expanded. The expansionmay be performed, for example, by differential movement, along devicelongitudinal axis LD, of proximal portion 2912 of support cage 2902 andproximal portion 2914 of anchoring substrate 2904. During deployment,anchor 2907 and 2908 may be inserted after expansion of device 2900.

Device 2900 may include relative displacement actuator 2910 foreffecting the differential displacement. Actuator 2910 may includethreaded support cage base 2916. Threaded support cage base 2916 may belongitudinally fixed to proximal end 2912 of support cage 2902. Threadedsupport cage base 2916 may include a first threaded longitudinal bore(not shown).

Actuator 2910 may include double threaded anchoring substrate base 2918.Double threaded substrate base 2918 may be fixed to proximal portion2914 of anchoring substrate 2904. Double threaded substrate base 2918may have outer threads 2920 that may be screwed into the firstlongitudinal threaded bore of support cage base 2916. Double threadedsubstrate base 2918 may include a second threaded longitudinal bore (notshown).

Actuator 2910 may include threaded central axis member base 2922.Threaded central axis member base 2922 may be fixed to the proximal endof central axis member 2906. Threaded central axis member base 2922 mayhave outer threads 2924 that may be screwed into the second threadedlongitudinal bore in double threaded substrate base 2918.

One or more control instruments may be deployed by catheter to rotateone or more of cage base 2916, double threaded anchoring substrate base2918 and threaded central axis member base 2922 to achieve desireddisplacement or displacements between the proximal portions of supportcage 2902, anchoring substrate 2904 and central axis member 2906. Thedifferential displacements may expand the device during deployment.

After deployment of device 2901, anchors 2907 and 2908 may be insertedthrough bone segments P1 and P2, respectively, into anchoring substrate2904. After insertion of anchors 2907 and 2908, relative displacementactuator 2910 may be used to adjust the stress state of bone segments P₁and P₂. For example, double threaded anchoring substrate base 2918 maybe rotated such that it moves in proximal direction DP relative tosupport cage base 2916. This relative motion would draw bone segments P₁and P₂, relative to support cage 2902, in proximal direction DP and ininward radial direction −R_(D).

After appropriate positioning of device 2900 and appropriate relativedisplacement of support cage 2902 and anchoring substrate 2904, aproximal anchor such as 1922 (shown in FIG. 19) may be inserted throughfemur B_(F) and anchoring substrate 2904 to hold device 2900 in place.

FIG. 30 shows a cross-sectional view of device 2910 taken along lines29-29 in FIG. 29. FIG. 29 shows threaded support cage base 2916longitudinally fixed to proximal portion 2912 of support cage 2902.Double threaded anchoring substrate base 2918 is threaded into the firstthreaded bore of support cage base 2916. Double threaded anchoringsubstrate base 2918 is longitudinal fixed to proximal portion 2914 ofanchoring substrate 2904. Threaded central axis member 2922 is threadedinto the second threaded bore of double threaded anchoring substratebase 2918. Central axis member 2906 extends in distal direction (−D_(P))from threaded central axis member 2922.

FIG. 31 shows illustrative balloon-expandable fracture repair device3100. Device 3100 may include outer structural member 3102. Outerstructural member 3102 may include structural cage 3104, stem 3106 anddevice retention member 3108. Device 3100 may include anchoring member3110. Anchoring member 3110 may include anchoring substrate 3112,anchoring member stem 3114 and device retention member 3116.

Structural cage 3104 and anchoring substrate 3112 may be positioned in acontracted state in an intramedullary space of a bone using deviceretention members 3108 and 3116, respectively. The device retentionmembers may be used to position structural cage 3104 and substrate 3112longitudinally relative to each other.

Balloon 3118 may be present inside anchoring substrate 3112. Catheter3120 may provide appropriate gas pressure for inflation of anchoringsubstrate 3112.

Membrane 3130 may be present about outer structural member 3102.Membrane 3130 may substantially entirely cover device 3130. Membrane3130 may be disposed on the exterior or interior of device 3100, orbetween described elements of device 3100.

Membrane 3130 may include elastic material. Membrane 3130 may includenon-elastic material. Membrane 3130 may include woven polyester, EPTFEfilm, a PET balloon, a silicon film, a polyurethane film, any suitablematerial that may be produced in a film form, any suitable material thatmay inhibit tissue growth, any suitable biocompatible, biodegradableand/or bioabsorbable material, and any other suitable material.

Membrane 3130 may facilitate the removal of the device 100 by inhibitingbone growth into device 100. In some embodiments, membrane 3130 mayinhibit ingrowth of tissue in interstitial spaces of device 3100.

In some embodiments, membrane 3130 may facilitate the delivery orrecapture of material that may be used in connection with device 3100,such as bone cement.

Membrane 3130 may be structurally integrated into device 3100. Membrane3130 may be configured to be used with device 3100 as an ancillary oraccessory component. The component may be used as needed for fracturerepair.

In some embodiments, membrane 3130 may be used to expand structural cage3104. In some embodiments, membrane 3130 may be used to expand anchoringsubstrate 3112. In such embodiments, membrane 3130 may be detachablefrom structural cage 3104 and/or anchoring substrate 3112. Membrane 3130may then remain implanted in the intramedullary space IS.

In some embodiments, membrane 3130 may be removable independently ofother elements of device 3100.

Membrane 3130 may include an agent. The agent may be impregnated inmembrane 3130. The agent may be present as a coating on membrane 3130.The agent may provide a bone growth promotion agent, a bone growthinhibition or prohibition agent, a drug eluting agent or any othersuitable agent.

FIG. 32 shows a cross sectional view taken along lines 32-32 of device3100. FIG. 32 shows catheter 3120 entering anchoring substrate 3112.Balloon 3118 may be filled from ports 3122 in catheter 3120. Anchoringsubstrate contour 3124 may be predetermined by its materials andconstruction (or both).

FIG. 33 shows illustrative anchoring member 3300. Anchoring member 3300may be used in a device such as device 3100 (shown in FIG. 31) and maycorrespond to anchoring member 3110. Anchoring member 3300 may includedistal ring 3302, anchoring substrate 3304, stem 3306 and deviceretention member 3308.

In some embodiments, a balloon such as 3118 (shown in FIG. 31) may beinserted inside anchoring member 3300 to expand anchoring member 200. Insome embodiments, device 3300 may be self-expanding.

Collar 3302 has a substantially fixed radius and may not expand. Collar3302 may include rings 3303. Rings 3303 may be arranged in a nestedconfiguration in which rings 3303 are partially or substantiallyperpendicular to axis L_(D). Rings 3303 may be coaxial with axis L_(D).In such configurations, rings 3303 may facilitate coupling to a centralaxis member such as 124 (shown in FIG. 1) and/or a structural cage suchas 105 (shown in FIG. 1).

When a balloon is used for expansion, the balloon may be situated asufficient distal distance away from stem 3306 so that the radius ofstem 3306 remains substantially the same during expansion of theballoon.

Anchoring substrate 3304 may include expansion band 3310. Expansion band3310 includes expansion cells such as 3312, which may deform alongdirections C_(D) and −C_(D) under radially outward (direction RD) stressfrom the expanding balloon. Band 3310 has a number of expansion cellsalong its circumference. The number of expansion cells along thecircumference of a band such as 3310 is referred as the cell density.

Groups of cells that are relatively expandable in response to alongitudinal compression may be considered to have a high “expansionratio.” Groups of cells that are relatively inexpandable in response tothe same longitudinal compression may be considered to have a low“expansion ratio.” Variations in cell density, cell shape, cell “leg”(material bordering the cell that separates the cell from other cells ormaterial) (or “strut”) length, cell leg thickness and other suitableparameters may be used to vary the expansion ration.

Anchoring substrate 3304 may include expansion band 3314. Expansion band3314 has a cell density that is greater than the cell density of band3310. When subjected to outward radial force from the balloon, expansionband 3314 will thus expand in radial direction R_(D) more than expansionband 3310 will expand. Expansion band 3316 has the same cell density asexpansion band 3314. Expansion band 3318 has the greatest cell densityand therefore may expand in radial direction R_(D) more than the otherexpansion bands.

The longitudinal variation in cell density along longitudinal anchoringsubstrate 3340 may result in a radial expansion that varies. Celldensity, band width (such as band 3316 width 3318) and band positionalong axis L_(D) may be chosen to provide an expanded contour ofanchoring substrate 3304 that conforms in a desired way to a supportcage such as 105 (shown in FIG. 1) or an intramedullary space such as IS(shown in FIG. 1). Circumferential variations (in direction C_(D)) incell density may provide circumferentially varying expansion radii. Suchvariations may be used to provide an anchoring substrate that has acontour that corresponds to, or contours with, an asymmetricintramedullary cavity, such as at the end of a humerus.

FIG. 34 shows illustrative anchoring substrate 3402 for a fracturerepair device in accordance with the principles of the invention.Anchoring substrate 3402 may be supported at distal end 3404 by flange3406. Anchoring substrate 3402 may be supported at proximal end 3408 byflange 3410. Central axis member 3412 may be longitudinally fixed toflange 3406. Flange 3410 may be substantially free to translate withrespect to central axis member 3412. This allows distance T between theflanges to decrease so that anchoring substrate 3402 can expand inradial direction R_(D).

Device 3400 may be self-expanding. Anchoring substrate 3402 may includebraided mesh. In some embodiments, device 3400 may include multipleanchoring substrates.

FIG. 35 shows anchoring substrate 3414 in an expanded state betweenflanges 3406 and 3410. Flange 3410 has been moved distally up centralaxis member 3412. Anchoring substrate 3414 corresponds to anchoringsubstrate 3402 (shown in FIG. 34), but may have a longitudinally varyingcell density and may therefore expand to a greater radius then cananchoring substrate 3402.

After anchors are attached to anchor substrate 3414, flange 3410 may bedrawn proximally to reduce the diameter of the substrate and apply atensile force to the attached anchor elements. During such diameterreduction, the shape of the cells in anchoring substrate 3414 maychange. For example, the cells may, in the expanded state, be generallysquare. In the contracted (or relatively contracted) state, the cellsmay be diamond-shaped or trapezoidal. The shape change may increase thestrength of the engagement between the anchoring substrate 3414. Theshape change may effectively lock the anchor into anchoring substrate3414.

FIG. 36 shows illustrative anchoring substrate 3600 for a fracturerepair device in accordance with the principles of the invention.Anchoring substrate 3600 may be attached to a central axis member (notshown). Anchoring substrate 3600 may be welded, crimped, woven orotherwise attached to the central axis member along the length of thecentral axis member. For example, radially inner portions 3602 may beattached to the central axis member.

In some embodiments, anchoring substrate 3600 may be attached at itsdistal and proximal ends to a central member such as 124 (shown inFIG. 1) and along its length to a structural cage such as 105 (shown inFIG. 1). This type of attachment may to facilitate wrapping or foldingthrough relative rotation between the cage and central member. In someembodiments, anchoring substrate 3600 may be present within a structuralcage such as 105 (shown in FIG. 1), but may be unattached or uncoupledto the structural cage.

Anchoring substrate 3600 may have sufficient elasticity to retain folds3603. Surfaces 3604 and radially outer portions 3606 may engage anchorsthat press bone segments against a support cage such as 105 (shown inFIG. 1). Anchoring substrate 3600 may include secondary folds 3608 toincrease the availability of surfaces 3604 to receive anchors.

The central axis member may be rotated in direction −C_(D) to draw theanchors inward in direction −R_(D) approximately toward the central axismember. The central axis member may be drawn proximally to applylongitudinal force to the bone segments.

FIG. 37 shows illustrative anchoring substrate 3700 for a fracturerepair device in accordance with the principles of the invention.Anchoring substrate 3700 may be constructed, attached to a central axismember and actuated as is anchoring substrate 3600 (shown in FIG. 36).Anchoring substrate 3700 may include primary folds 3702. Anchoringsubstrate 3700 may not include secondary folds such as 3608 in anchoringsubstrate 3600.

Some embodiments may include threadlike elements that are intertwinedwith anchoring substrate 3600 and/or a structural cage such as 105(shown in FIG. 1). The threadlike elements may be connected to thecentral axis member to facilitate drawing portions of the anchoringsubstrate or structural cage toward the device axis. In someembodiments, the threadlike elements may be pulled through the centralaxis member by a delivery instrument.

FIG. 38 shows illustrative anchoring substrate 3800 for a fracturerepair device in accordance with the principles of the invention.Anchoring substrate 3800 may be attached to a central axis member (notshown). Anchoring substrate 3800 may be welded, crimped or otherwiseattached to the central axis member near a proximal end of the centralaxis member. For example, radially inner and proximal portions 3802 maybe attached to the central axis member. Anchoring substrate may havesufficient elasticity to retain helical folds 3803. Folded surfaces 3804may engage anchors that press bone segments against a support cage suchas 105 (shown in FIG. 1).

Distal end 3808 of anchoring member 3800 may be fixed to a flange, suchas 3406 (shown in FIG. 35). The central axis member may be free torotate in direction −C_(D) with respect to the flange. When the centralaxis member is so rotated, it may tighten helical folds 3803 and drawthe anchors inward in direction −R_(D) approximately toward the centralaxis member. The central axis member may be drawn proximally to applylongitudinal force to the bone segments.

FIG. 39 shows illustrative anchoring substrate 3900 for a fracturerepair device in accordance with the principles of the invention.Anchoring substrate may include stacked disc-like folds 3902. Disc-likefolds may expand and contract longitudinally and radially in anaccordion-like fashion.

FIG. 40 shows anchoring substrate 3900 in cross-section as viewed alonglines 40-40 (shown in FIG. 39). When proximal end 3904 and distal end3906 (e.g., at flange 3908) are displaced longitudinally toward eachother, anchoring substrate 3900 may compress longitudinally anddisc-like folds 3902 may expand in direction R_(D). When proximal end3904 and distal end 3906 (e.g., at flange 3908) are displacedlongitudinally away from each other, anchoring substrate 3900 may extendlongitudinally and disc-like folds 3902 may contract in direction−R_(D).

The longitudinal extension may be used to deploy anchoring substrate ina radially compressed state. After deployment, anchoring substrate maybe longitudinally compressed so that folds 3902 expand in radialdirection R_(D). Anchors may then be engaged with folds 3902. Anchoringsubstrate 3900 may then be longitudinally extended to apply radiallyinward force to the anchors. Tension in direction DP may then be appliedto the anchors by pulling proximal end 3904. Folds 3902 may be biased atangle B in direction −D_(P) so that when end 3904 is pulled, fold axesLf are pre-aligned with the anchors.

Proximal portion 3904 may be attached to a pull member (not shown) thatmay be similar to a portion of a central axis member such as 124 (asshown in FIG. 1B). Distal end 3906, at flange 3908, may be attached to aportion of the device that remains substantially longitudinallystationary when the pull device pulls on proximal portion 3904. Forexample, flange 3908 may be fixed to the distal end of a correspondingsupport cage such as 105 (shown in FIG. 1).

FIG. 41 shows illustrative support cage 4100 for a fracture repairdevice in accordance with the principles of the invention. Support cage4100 may include hub 4102 and base ring 4104. Spiral support members4106 extend between hub 4102 and base ring 4104. A central axis member(not shown) may extend along device axis L_(D). The central axis membermay have a distal end that is longitudinally fixed to hub 4102. Thecentral axis member may extend through base ring 4104. Base ring 4104may be moved along the central axis member. When base ring 4104 is movedaway from hub 4102, spiral support members 4106 may extendlongitudinally and straighten. As spiral support members 4106straighten, ring 4104 may rotate.

Longitudinal extension of support cage 4100 may configure support cage4100 for deployment. Longitudinal compression of support cage 4100 mayconfigure support cage 4100 for deployment and engagement with bonesegment anchors. In some embodiments, support cage 4100 may be expandedand collapsed by application of an external rotational force.

In some embodiments, support cage 4100 may be self-expanding. In thoseembodiments, support cage 4100 may have a relaxed state that islongitudinally compressed. Support cage 4100 may be longitudinallyextended for deployment. Support cage 4100 may then return to itsrelaxed state after deployment.

FIG. 42 shows illustrative hybrid support cage and anchoring substrate4200. Hybrid cage/substrate 4200 may include support members 4202.Support members 4202 may support bone segments such as P_(a), P_(h) andP_(B) (shown in FIG. 1). Hybrid cage/substrate 4200 may includesubstrate members 4204 for engaging anchors such as 114 and 116 (shownin FIG. 1). Substrate members 4204 may be supported by support members4202. Substrate members 4204 and 4202 may expand and contract radiallyas a single unit.

Hybrid cage/substrate 4200 may include stem 4206 and device retentionmember 4208. Support members 4202 may be integrated with substratemembers 4204 in a single-layer structure. Substrate members 4204 mayhave features that are described herein in connection with anchoringsubstrates such as 112 (shown in FIG. 1). For example, the substratemembers 4204 may be formed to facilitate anchor mating and retention.Hybrid cage/substrate 4200 may be used alone or in concert with layersof other hybrid cage/substrates like 4200 or with layers of otherconstructs such as devices previously described herein like central axismember 2502 (shown in FIG. 25), intermediate member 2507 (shown in FIG.25), anchoring member 3300 (shown in FIG. 33) and outer member 2514(shown in FIG. 25).

FIG. 43 shows illustrative fracture repair device 4300 in accordancewith the principles of the invention. Device 4300 includes anchoringsubstrate 4302 and support cage 4304. Anchoring substrate 4302 isradially outside support cage 4304. Device 4300 may include distal hub4306. Distal hub 4306 may provide support for proximal end 4308 ofcentral axis member 4310. Proximal base 4312 may support proximalportions of anchoring substrate 4302 and support cage 4304. Central axismember 4310 may pass through proximal base 4312. Central axis member4310 may support device retention member 4314.

FIG. 44 shows illustrative fracture repair device 4400 in accordancewith the principles of the invention. Device 4400 may include structuralcage 4402 and anchoring substrate 4404. Device 4400 may include bushing4406 for sliding proximal portion 4408 of structural cage 4402 alongcentral axis member 4410. Device 4400 may include bushing 4412 forsliding proximal portion 4414 of anchoring substrate 4404 along centralaxis member 4410. The bushings may support device retention members suchas 1802 (shown in FIG. 18). The device retention members may be used toexpand and contract device 4400. Spherical or sphere-like embodiments ofdevice 440 may provide a high radial compression strength, and generatehigh radial compression forces, based on the shape.

FIG. 45 shows illustrative fracture repair device 4500 in accordancewith the principles of the invention. Device 4500 may include a train ofsubstantially spherical or sphere-like structural cages 4502, 4504 and4506 inside outer structural cage 4508. Device 4500 may include as manycages as desired to make a train of a desired length. In someembodiments, an anchoring substrate like 4300 (shown in FIG. 43) may bepresent. The anchoring substrate may be present within or outside ofstructural cage 4508.

In some embodiments, the cages may be partially spherical. An anchoringsubstrate is present inside each of the structural cages. Device 4500may include bushings 4510 and 4512 for positioning proximal end 4516 ofouter structural cage 4508 and proximal end 4514 of the train,respectively, along central axis member 4518. Central axis member 4518may be rigidly fixed at outer structural cage hub 4520. Structural cages4502, 4504 and 4506, outer structural cage 4508 and the anchoringsubstrates may be expanded and collapsed by sliding bushings 4510 and4512 along central axis member 4518.

FIG. 46 shows illustrative fracture repair device 4600 in accordancewith the principles of the invention. Device 4600 is shown in long boneB_(L) in a view that is similar to the view of device 4500 along lines46-46 that is shown in FIG. 45. Device 4600 may include a train ofsubstantially spherical structural cages 4602, 4604 and 4606 insideouter structural cage 4608. Device 4600 may transect fracture F_(L).

An anchoring substrate may be present inside each of structural cages4602, 4604 and 4606. Device 4600 may include device retention member4610. Device retention member 4610 may be configured to slide relativeto central axis member 4612. Central axis member 4612 may terminateproximally at device recapture member 4614. Central axis member 4612 mayterminate distally at outer structural cage hub 4616, to which centralaxis member 4612 may be rigidly fixed.

Structural cages 4602, 4604 and 4606, outer structural cage 4608 and theanchoring substrates may be expanded and collapsed by sliding deviceretention member 4610 relative to device recapture member 4614.Ratcheted bushings 4618 may be present to retain device 4600 in anexpanded state. After device 4600 is expanded, anchors 4620, 4622 and4624 may be inserted through bone segments B_(L1) and B_(L2) to engagethe anchoring substrates.

A compressive traction may be applied to fracture FL by initiallyinserting anchors 4620 and 4622, drawing device 4600 in proximaldirection D_(P) relative to bone segment B_(L2), and subsequentlyinserting anchor 4624.

FIG. 47 shows illustrative fracture repair device 4700 in accordancewith the principles of the invention. Device 47 is shown deployed inintramedullary space IS of long bone B_(L). Device 47 bridges acrossfracture F_(L). Device 47 may include structural cage 4702. Device 47may include anchoring substrate 4704. Structural cage 4072 may bedeployed in intramedullary space IS. Structural cage 4072 may provideradially outward support to bone segments B_(L1) and B_(L2). Anchoringsubstrate 4704 may be deployed within structural cage 4072.

Anchoring substrate 4704 may be engaged by anchors 4706, 4708, 4710 and4712 to stabilize bone segments B_(L1) and B_(L2) against structuralcage 4702. A compressive traction may be applied to fracture FL byinitially inserting anchors 4706 and 4708, drawing device 4700 inproximal direction DP relative to bone segment B_(L2), and subsequentlyinserting anchors 4710 and 4712.

Device 4700 is shown with substantially open ends. In some embodiments,device 4700 may have ends that terminate at a hub or a base, such as areshown and described herein. Device 4700 may be used as shown or inconjunction with other devices that are shown and described herein.

FIG. 48 shows illustrative anchor 4800 that may be used with a fracturerepair device in accordance with the principles of the invention. Anchor4800 may include elongated member 4802, head 4804 and tabs 4806. Anchor4800 may be deployed using torque, axial pressure or both. Elongatedmember 4802 may be inserted through a bone segment. Tabs 4806 may beelastically deformable so that when anchor 4800 is inserted through thebone segment, tabs 4806 lie substantially even with the outer surface ofelongated member 4802.

End 4808 may pass through a cell in an anchoring substrate such as 112(shown in FIG. 1). One or more of tabs 4806 may engage the anchoringsubstrate and prevent anchor 4800 from being disengaged from theanchoring substrate. Tabs 4806 may deflect to lie substantially evenwith the outer surface of elongated member 4802 when anchor 4800penetrates the anchoring substrate.

In some embodiments, tabs 4806 may have a predeployment state in whichtabs 4806 may lie substantially even with the outer surface of elongatedmember 4802. Tabs 4806 may be deployed after anchor 4800 is insertedthrough the bone and the anchoring substrate. Tabs 4806 may be deployedby inserting an actuator shaft (not shown) in the lumen of elongatedmember 4802. The actuator shaft may push tabs 4806 radially outward.

Tabs 4806 may include an extensions (not shown) that extend into thelumen of anchor 4800. The extensions may be extend away from the “plane”of the tabs. The extensions may facilitate the deployment of the tabswhen the actuator shaft is driven down the lumen and contacts theextensions.

Elongated member 4802 may be constructed from tube stock. Tabs 4806 maybe punched or laser cut from the tube. Head 4804 may be welded toelongated member 4802. Head 4804 may include driver receptacle 4804. Thediameter of the tube stock may be selected to correspond to that of theanchoring substrate cells to maximize the interference (and between tabs4806 and the anchoring substrate. Such selection may provide suitableretention of the anchors.

FIG. 49 shows illustrative anchor 4900 that may be used with a fracturerepair device in accordance with the principles of the invention. Anchor4900 may include elongated member 4902, head 4904 and thread segments4906. Anchor 4900 may be deployed using torque, axial pressure or both.Elongated member 4902 may be inserted through a bone segment. Threadsegments 4906 may be elastically deformable to ease insertion in thebone segment and engagement with the anchoring substrate. Parameters ofthread segments 4906 may be selected for engagement with an anchoringsubstrate. The parameters may include minor diameter, major diameter,pitch and any other suitable parameters.

Thread segments 4906 may include circumferential faces 4908 andcorresponding circumferential locking faces 4910. Circumferentiallocking faces 4910 may catch in the anchoring substrate and preventanchor 4900 from unscrewing from the anchoring substrate.

FIG. 50 shows illustrative anchor 5000 that may be used with a fracturerepair device in accordance with the principles of the invention. Anchor5000 may include elongated member 5002, head 5004 and thread segments5006. Thread segments 5006 may have some or all of the features ofthread segments 4906 (shown in FIG. 49). For example, thread segments5006 may include circumferential faces 5008 and correspondingcircumferential locking faces 5010. Circumferential locking faces 5010may catch in the anchoring substrate and prevent anchor 5000 fromunscrewing from the anchoring substrate.

Anchor 5000 may be deployed using torque, axial pressure or both.

Anchor 5000 may include articulating catch 5012. Articulating catch 5012may in a non-deployed state be present in lumen 5014 of elongated member5002. Rod 5014 may be depressed in lumen 5014 and may push on leg 5018of catch 5012. Leg 5018 may urge hinge 5020 out of port 5022 inelongated member 5002. Corresponding catch 5024 may be deployed in asimilar fashion. Legs 5018 and 5026 may catch in the anchoring substrateafter deployment of catches 5012 and 5024. Anchor 5000 may thus belocked to the anchoring substrate.

FIG. 51 shows illustrative anchor 5100 that may be used with a fracturerepair device in accordance with the principles of the invention. Anchor5100 may include spiral member 5102, head 5104 and notches 5106. Anchor5100 may be deployed using torque, axial pressure or both.

Elongated member 5102 may be inserted through a bone segment. A pilothole in the bone segment may have a diameter corresponding to diameter dof spiral member 5102. Spiral member 5102 may thus pass through the bonesegment without substantial rotation. In some embodiments, an anchoraccess hole in the bone could be made for anchor 5100. The anchor accesshole may have a diameter that is no smaller than diameter d′ ofelongated member 5102 and is large enough to allow elongated member 5102to be helically threaded thru the hole. Such an access hole may besmaller than a standard anchor hole.

Tip 5108 may then engage the anchoring substrate. Rotation of anchor5100 may then drive anchor 5100 relatively deeper into the anchoringsubstrate. Notches 5106 may catch in the anchoring substrate and preventanchor 5100 from rotating out of engagement with the anchoringsubstrate. End portion 5110 may be provided without notches so thatanchor 5100 may be backed out of the anchoring substrate, if desired,before driving anchor 5100 into a locked relationship with the anchoringsubstrate.

FIG. 52 shows illustrative anchor 5200 that may be used with a fracturerepair device in accordance with the principles of the invention. Anchor5200 may include elongated member 5202, head 5204 and catch 5206. Catch5206 may be supported by and rotatable about pin 5208. Catch 5206 may ina nondeployed state be present or partially present in slot 5210 inelongated member 5202. For example, catch 5206 may rotate in direction msuch that tip 5212 rotates into slot 5210 and tip 5214 rotates into aposition that extends beyond elongated member 5202.

In such a configuration, elongated member 5202 may be inserted through abone segment. Tip 5214 may then traverse a portion of the anchoringsubstrate. After the traverse, tip 5214 may rotate in the −m directionsuch that anchor 5200 returns to the configuration shown in FIG. 52. Thespan of catch 5206 may exceed the diameter of a cell in the anchoringsubstrate. Anchor 5200 may thus be locked to the anchoring substrate.

In some embodiments, screw-actuator 5216 may be present in bore 5218 ofelongated member 5202. Screw-actuator 5216 may be screwed into the bore.This action may reduce the effective length of anchor 5200 and,therefore tension the bone segment to the anchor substrate. In someembodiments, a tip (not shown) of screw-actuator 5216 may deflect tip5212 out of slot 5210 to rotate catch 5206. Tip 5212 may be beveled tofacilitate deflection by the tip of screw-actuator 5216.

FIG. 53 shows anchors 5200 deployed and locked into anchoring substrate112 of device 100 (shown also in FIG. 1). Anchors 5200 thus fasten bonesegments Pa and Ph to anchoring substrate 112.

FIG. 54 shows illustrative fracture repair device 5400 in accordancewith the principles of the invention. Device 5400 is implanted in boneB. Wire 5402 passes through holes that are drilled through bone segmentP_(a), anchoring substrate 5404 and bone segment PB to form loop 5406.The ends of wire 5402 may be fastened to each other to secure boneportions P_(a), P_(h) and P_(B) to each other.

FIG. 55 shows illustrative fracture repair device 5500 in accordancewith the principles of the invention. Device 5500 is shown deployed andlocked in humerus B_(H). Support members 5502 generally conform to thecontours of intramedullary space IS in bone B_(H). Anchoring substrateapplies tension in direction D_(P) to anchors 5504 and 5506. Proximalanchor 5508 retains the tension.

Expanding cylindrical anchor 5510 is present coaxially about structuralcage base 5512. Anchor 5510 may expand radially when compressed alongaxis L_(D). When anchor 5510 expands, circumferential blades 5514 extendradially into bone B_(H). Anchor 5510 may be compressed bylongitudinally fixing distal end 5516 at a position on structural cagebase 5512 and pushing distally on proximal end 5518. A detent (notshown) may be provided to prevent anchor 5510 from extendinglongitudinally. When locked in the compressed state, anchor 5510 cutsinto bone B_(H) and locks device 5500, or parts thereof, longitudinally.Anchor 5510 may be self-expanding when released from constraint. Anchor5510 may be rotated during expansion to promote engagement with thebone.

Expanding cylindrical anchor 5522 is shown connected directly toanchoring substrate 5530. Anchor 5522 may be locked after a desiredtension is obtained in device 5500. Expanding cylindrical anchor 5522may have some or all of the features of expanding cylindrical anchor5510.

FIG. 56A shows illustrative expanding anchor 5600 that may be used inaccordance with the principles of the invention. Anchor 5600 may havesome or all of the features of anchor 5510 (shown in FIG. 55). Anchor5600 may be cut from a tube. Compression along axis L_(D) causesarticulation of living hinge 5604. The articulation causes blades 5602to extend radially away from axis L_(D). Anchor 5600 may beself-expanding.

FIG. 56B shows a view of anchor 5600 from direction 56B-56B (shown inFIG. 56A). FIG. 56C shows a view of anchor 5600 from direction 56C-56C(shown in FIG. 56A).

FIG. 57A shows illustrative expanding helical anchor 5700 that may beused in accordance with the principles of the invention. Helical anchor5700 may have some or all of the features of anchor 5510 (shown in FIG.55). Anchor 5700 may be cut from a tube. Compression along axis L_(D)causes articulation of living hinge 5704. The articulation causes blades5702 to extend radially away from axis L_(D). Anchor 5700 may beself-expanding.

FIG. 57B shows a view of anchor 5700 from direction 57B-57B (shown inFIG. 57A). FIG. 57C shows a view of anchor 5700 from direction 57C-57C(shown in FIG. 56A).

When helical anchor 5700 is rotated relative to surrounding bone, it maymove like a screw because of the helical form of blades 5702. Whenhelical anchor 5700 is rotated compressed and rotated simultaneously,blades 5702 may carve out bone material while anchor 5700 is beingengaged in the bone. Carving out the bone material may reduce hoopstress in the bone.

FIG. 58 shows illustrative bone fracture repair device 5800 inaccordance with the principles of the invention in femur BF. Device 5800includes structural cage 5802 and anchoring substrate 5804. Anchors 5806fasten portions (individual bone segments not shown) of femur B_(F) toanchoring substrate 5804. Structural cage 5800 may include cage base5808 which may be configured to receive proximal anchor 5810. Proximalanchor 5810 may apply tension to central axis member 5812. Proximalanchor 5810 may apply tension to anchoring substrate 5804.

Device 5800 may be introduced at a site near point on bone B_(F) so thatdevice 5800 may be delivered in an orientation and at a position that isclose to the desired deployed orientation and position.

Buttress plate 5816 may be present adjacent bone BF. Buttress plate 5816may provide stability to anchors an 5814. Buttress plate 5816 maydistribute forces from anchors 5806 and 5814 to different portions ofbone B_(F). Buttress plate 5816 may accommodate as many anchors 5806 asappropriate to secure the fracture. Buttress plate 5816 may havespecially constructed mating features to lock device at a desired anglewith respect to buttress plate 5816.

FIG. 59 shows illustrative bone fracture repair device 5900 inaccordance with the principles of the invention in humerus B_(H). Insome embodiments, device 5900 may be completely delivered and deployedthrough a single access hole (not shown). Device 5900 includesstructural cage 5902. Structural cage 5902 may provide outward radialand longitudinal support for bone segments P, P₁ and P₂.

Anchors may be delivered by steerable catheter into bone BH and througha cage base such as 108 (shown in FIG. 1). Tethers 5904 and 5906 mayapply inward radial and proximal tension to bone segments P₁ and P₂,respectively. The tethers may be delivered into humerus BH through anaccess hole (not shown) that is proximal device 5900. Device may notinclude an anchoring substrate.

T-bar anchor 5908 may anchor tether 5904 to bone segment P₁. T-baranchor 5908 may have some or all of the features of anchor 5200 (shownin FIG. 52). Screw-type anchor 5910 may anchor tether 5906 to bonesegment P₂.

The tethers may be delivered through flared support tube 5912. Flaredsupport tube 5912 may include one-way cleat 5914. The tethers may bedrawn in proximal direction Pd to apply tension to the bone segments.One-way cleat 5914 may prevent release of the tension.

FIG. 60 shows illustrative bone fracture repair device 6000 inaccordance with the principles of the invention in humerus B_(H). Device6000 includes structural cage 6002. Structural cage 6002 may provideoutward radial and longitudinal support for bone segments P, P₁ and P₂.Structural cage 6002 and anchoring substrate 6004. Anchors 6006, 6008and 6010 may be delivered by steerable catheter through cage base 6012and into the interior of anchoring substrate 6004. The anchors may thenbe inserted in bone segments P₁ and P₂. The steerable catheter may thenbe withdrawn. Anchoring substrate 6004 may then be drawn in proximaldirection D_(P) using approaches shown and described herein or othersuitable methods. Drawing anchoring substrate 6004 in direction D_(P)may compress bone segments P₁ and P₂ against bone segment P.

FIG. 61 shows illustrative bone fracture repair device 6100 inaccordance with the principles of the invention in bone B. Device 6100may be delivered to intramedullary space IS of bone B through accesshole 6101 in radial styloid S.

Device 6100 may include structural cage 6102, anchoring substrate 6104and central axis member 6106. Structural cage 6102 may include hub 6108,where support members 6110 rigidly join. Hub 6108 may support deviceretention member 6112.

Delivery sheath 6114 may provide access to intramedullary space throughstyloid S. Delivery instruments (not shown) may extend through deliverysheath 6114 and engage device retention member 6112 for positioning anddeployment of device 6100.

FIG. 62 shows illustrative plate 6200 that may be used in connectionwith a bone fracture repair device in accordance with the principles ofthe invention. Plate 6200 includes a plurality of holes 6202 for passageof anchors.

Plate 6200 may support bone segments and a device such as 6300 (shown inFIG. 63) that is inside a bone. Plate 6200 may be used during an opensurgical procedure on the outer surface of the bone. Plate 6200 may bestiff or flexible. The shape of late 6200 may be selected for thecapture of some or all of the bone segments of the bone.

FIG. 63 shows illustrative bone fracture repair device 6300 inaccordance with the principles of the invention. Device 6300 may be usedin connection with a plate such as 6200 (shown in FIG. 62). Device 6300may include structural cage 6302 and anchoring substrate 6304. Anchorssuch as spiral anchors 6306 may be passed through holes 6202 and bonesegments P_(B) and P_(a). Anchors 6306 may have some or all of thefeatures of anchors 5100 (shown in FIG. 51). Anchors 6306 may anchor in,and lock to, anchoring substrate 6304.

FIG. 64 shows device 4600 (shown in FIG. 46) deployed inside vertebra V.Device 4600 provides outward radial support. Device 4600 may be used invertebra V without anchors.

FIG. 65 shows an illustrative scenario for providing access to proximalhumerus PH. Introducing instrument 6502 may provide an access hole inproximal humerus PH. Device 6504 may be introduced, positioned, deployedand anchored near the end of proximal humerus PH. Imaging device 6506may be provided to provide visual information about the location ofanatomical features of proximal humerus PH and device 6504.

FIG. 66 shows an illustrative scenario for deploying illustrative bonefracture repair device 6600 in accordance with the principles of theinvention in open fracture F_(h) of bone B. Device 6600 may includestructural cage 6602, anchoring substrate 6604 and central axis member6606. Device 6600 may be inserted into intramedullary space of bone Bvia fracture F_(h). Device 6600 may be inserted in a contracted state.Device 6600 may be inserted in an expanded state.

FIG. 67 shows illustrative anchoring substrate 6700 that may be usedwith a fracture repair device in accordance with the principles of theinvention. Anchoring substrate 6700 may include elongated portion 6702.Elongated portion 6702 may be terminated with end cap 6704. One or bothof elongated portion 6702 and end cap 6704 may include holes 6706. Holes6706 may be engaged with anchors to hold bone segments in place.

Anchoring substrate 6700 may be used for repairing bones having openfractures such as fracture F_(h) of bone B as shown in FIG. 66.Anchoring substrate 6700 may be expandable. Anchoring substrate may benon-expandable.

Apparatus and methods described herein are illustrative. Apparatus andmethods of the invention may involve some or all of the features of theillustrative apparatus and/or some or all of the steps of theillustrative methods. The steps of the methods may be performed in anorder other than the order shown and described herein. Some embodimentsof the invention may omit steps shown and described in connection withthe illustrative methods. Some embodiments of the invention may includesteps that are not shown and described in connection with theillustrative methods.

Processes in accordance with the principles of the invention may includeone or more features of the processes illustrated in FIG. 68. Some stepsof the processes may be performed in an inpatient setting. Some steps ofthe processes may be performed in an outpatient setting.

FIG. 68 shows illustrative steps of process 6800 for repairing afracture. Process 6800 may begin at step 6802. At step 6802, a caregivermay provisionally reduce the fracture. At step 6804, the caregiver mayestablish access to the intramedullary cavity in the fractured bone. Atstep 6806, the caregiver may insert a catheter into the fractured bone.At step 6808, the caregiver may confirm positioning of the catheterusing fluoroscopy (or any other suitable imaging approach). At step6810, the caregiver may deploy a structural support such as structuralcage 105 (shown in FIG. 1). At step 6812, the caregiver may deploy ananchoring substrate such as anchoring substrate 112 (shown in FIG. 1).At step 6814, the caregiver may insert anchors into the bone segmentsand anchoring substrate. At step 6815, the caregiver may apply tension.The tension may be applied to one or more of an anchor, an anchoringsubstrate, a structural support or any of the apparatus shown anddescribed herein using any of the approaches shown and described herein.At step 6816, the caregiver may confirm bone segment location usingmedical imaging. At step 6818, the caregiver may lock the insert devicesin the intramedullary cavity. At step 6820, the inserted devices may bedisengaged from the delivery system used to deliver the devices.

There are different combinations of implant sequences. Table 4 showsdifferent illustrative sequences of treatment steps. Other treatmentsteps and different sequences may also be practiced in accordance withthe principles of the invention.

TABLE 4 Illustrative fracture repair sequences. IllustrativeIllustrative sequence A Illustrative sequence B sequence C Reducefracture Anchor Manipulate segments Introduce device Manipulate segmentsEngage segments Anchor segment to Engage segments Anchor device Tensionassembly to Tension segments Provide tension to finalize reductionsegments Anchor assembly Anchor or secure Lock assembly segmentsDisengage from the Disengage Further appropriate assembly steps Furtherappropriate Further appropriate steps steps

There are numerous other steps that may be included. Differentembodiments of the apparatus shown and described herein may be used inconjunction with different steps of process 6800, whether or not shownin FIG. 68 or Table 4. For example, bone cement may be applied,cancellous autograph may be inserted, topical or internal antibioticsmay be administered and any other suitable therapies may be used.

Thus, apparatus and methods for fracture repair have been provided.Persons skilled in the art will appreciate that the present inventioncan be practiced by other than the described embodiments, which arepresented for purposes of illustration rather than of limitation. Thepresent invention is limited only by the claims that follow.

1. An apparatus for treating a fracture of a bone, the fractureincluding segments, the bone having an inner cavity, the apparatuscomprising: a structural support for positioning a first of the bonesegments relative to a second of the bone segments, the structuralsupport being configured to be deployed in the inner cavity; ananchoring substrate configured to maintain a position of the first bonesegment relative to the second bone segment, the anchoring substratebeing configured to be deployed in the inner cavity; a proximal anchorthat is configured to secure a proximal portion of the anchoringsubstrate to the bone; and, when the proximal anchor has a center axis,a detent configured to fix the distal end of the proximal anchor, withrespect to the center axis, to the structural support; wherein: theproximal anchor is substantially cylindrical and comprises blades thatextend radially outward; the proximal anchor includes a proximal end anda distal end; the blades move radially outward when the proximal anddistal ends are moved toward each other; and the proximal end of theproximal anchor is configured to be pushed distally to move the bladesradially outward.
 2. An apparatus for treating a fracture of a bone, thefracture including segments, the bone having an inner cavity, theapparatus comprising: a structural support for positioning a first ofthe bone segments relative to a second of the bone segments, thestructural support being configured to be deployed in the inner cavity;an anchoring substrate configured to maintain a position of the firstbone segment relative to the second bone segment, the anchoringsubstrate being configured to be deployed in the inner cavity; aproximal anchor that is configured to secure a proximal portion of theanchoring substrate to the bone; and, when the proximal anchor has acenter axis, a detent configured to rotatably fix a distal end of theproximal anchor, with respect to the center axis, to the structuralsupport; wherein: the proximal anchor is substantially cylindrical andcomprises blades that extend radially outward; the blades comprisehelical portions of the proximal anchor; and a proximal end of theproximal anchor is configured to be pushed distally and rotated aboutthe center axis to move the blades radially outward while the proximalanchor rotates about the center axis.
 3. Apparatus for repairing afractured bone, the apparatus comprising: a bone segment supportconfigured to be deployed inside the bone; an anchoring substrateconfigured to be deployed inside the bone; and a relative displacementactuator configured to displace a portion of the anchoring substraterelative to a portion of the bone segment support; wherein: the relativedisplacement actuator has a central axis and comprises: a firstdisplacing member fixed, with respect to the central axis, to the bonesegment support; and a second displacing member fixed, with respect tothe central axis, to the anchoring substrate; the first displacingmember is engaged with the second displacing member such that relativemotion, along the central axis, of the first and second displacingmembers changes the distance, along the central axis, between a portionof the bone segment support and a portion of the anchoring substrate;and the first displacing member is threadedly engaged with the seconddisplacing member.
 4. The apparatus of claim 3 wherein the bone segmentsupport is one of several bone segment supports that form a supportcage.
 5. The apparatus of claim 3 wherein: the bone segment support iselongated and comprises along its length a first bone segment supportportion and a second bone segment support portion; the first bonesegment support portion has a first bending resistance; the second bonesegment support portion has a second bending resistance; and the firstbending resistance is greater than the second bending resistance.
 6. Theapparatus of claim 3 wherein rotation of the first displacing memberrelative to the second displacing member causes displacement, along thecentral axis, between the portion of the bone segment support and theportion of the anchoring substrate.